maytansine profile

Maytansine: An ansa macrolide isolated from the MAYTENUS genus of East African shrubs. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

maytansine : An organic heterotetracyclic compound and 19-membered macrocyclic lactam antibiotic originally isolated from the Ethiopian shrub Maytenus serrata but also found in other Maytenus species. It exhibits cytotoxicity against many tumour cell lines. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Related Flora

Flora	Rank	Flora Definition	Family	Family Definition
Maytenus	genus	A plant genus of the family CELASTRACEAE.[MeSH]	Celastraceae	A plant family of the order Celastrales, subclass Rosidae, class Magnoliopsida.[MeSH]
Maytenus serrata	species	[no description available]	Celastraceae	A plant family of the order Celastrales, subclass Rosidae, class Magnoliopsida.[MeSH]

ID Source	ID
PubMed CID	5281828
CHEMBL ID	292702
CHEBI ID	6701
SCHEMBL ID	61357
MeSH ID	M0013148

Synonym
l-alanine, n-acetyl-n-methyl-, 11-chloro-21-hydroxy-12,20-dimethoxy-2,5,9,16-tetramethyl-8,23-dioxo-4,24-dioxa-9,22-diazatetracyclo(19.3.1.110,14.03,5)hexacosa-10,12,14(26),16,18-pentaen-6-yl ester, (1s-(1r,2s,3r,5r,6r,16e,18e,20s,21r*))-
maitansinum [inn-latin]
maytansine [usan]
brn 5417399
maitansina [inn-spanish]
einecs 252-754-7
n-acetyl-n-methyl-l-alanine(1s-(1r,2s,3r,5r,6r,16e,18e,20s,21r*))-11-chloro-21-hydroxy-12,20-dimethoxy-2,5,9,16-tetramethy-8,23-dioxo-4,24-dioxa-9,22-diazatetracyclo(19.3.1.1(sup 10,14).0(sup 3,5))hexacosa-10,12,14(26),16,18-pentaen-6-yl ester
D04864
maytansine (usan)
maytansine
nsc-153858
nsc 153858
LMPK04000017
unii-14083fr882
maitansina
maitansine [inn]
maitansinum
14083fr882 ,
chebi:6701 ,
CHEMBL292702
3gt ,
(3beta,4beta,5beta,10beta,11e,13e)-maytansine
SCHEMBL61357
maytansine [mi]
WKPWGQKGSOKKOO-RSFHAFMBSA-N
(4beta,5beta,11e,13e)-maytansine
bdbm50480257
DTXSID00879995
Q6720157
CS-0007711
HY-13674

Excerpt	Reference	Relevance
"Maytansine is a pharmacologically active 19-membered ansamacrolide derived from various medicinal plants and microorganisms. "	( New insights into the anticancer therapeutic potential of maytansine and its derivatives. Armaghan, M; Bagiu, IC; Bagiu, RV; Butnariu, M; Cho, WC; Habtemariam, S; Hassan, N; Khan, K; Kieliszek, M; Sharifi-Rad, J; Zafar, S, 2023)	2.6
"Maytansine is a potent microtubule-targeted compound that induces mitotic arrest and kills tumor cells at subnanomolar concentrations. "	( Maytansine and cellular metabolites of antibody-maytansinoid conjugates strongly suppress microtubule dynamics by binding to microtubules. Chari, R; Jordan, MA; Lopus, M; Oroudjev, E; Widdison, W; Wilhelm, S; Wilson, L, 2010)	3.25
"Maytansine is an experimental antitumor agent that has shown minimal efficacy against breast cancer with minimal myelosuppression in phase I trials. "	( Minimal single-agent activity of maytansine in refractory breast cancer: a Southwest Oncology Group study. Laufman, LR; McCracken, JD; Neidhart, JA; Vaughn, C, )	1.86
"Maytansine is a new drug undergoing clinical investigation. "	( Flow microfluorometric analysis of P388 murine leukemia after administration of vincristine and maytansine in vivo. Alabaster, O; Cassidy, M, 1978)	1.92

Excerpt	Reference	Relevance
"Maytansine has significant antitumor activity in animal model systems. "	( Maytansine: a phase I study of an ansa macrolide with antitumor activity. Blum, RH; Kahlert, T, 1978)	3.14

Excerpt	Reference	Relevance
"3 and 1 nM, respectively), with accumulation of cells arrested in mitosis at toxic concentrations, that both inhibited the polymerization of purified tubulin, and that both inhibited microtubule assembly dependent on microtubule-associated proteins."	( Halichondrin B and homohalichondrin B, marine natural products binding in the vinca domain of tubulin. Discovery of tubulin-based mechanism of action by analysis of differential cytotoxicity data. Bai, RL; Hamel, E; Herald, CL; Malspeis, L; Paull, KD; Pettit, GR, 1991)	0.28
" Some of these inhibitors (namely, colchicine, vinblastine, taxol, and maytansine) were found to exhibit large (between tenfold and fiftyfold) differences in their toxic and antimitotic concentrations toward various cell lines and these differences appeared to be species related inasmuch as all cell lines from a particular species showed similar sensitivities toward these inhibitors."	( Species-specific differences in toxicity of antimitotic agents toward cultured mammalian cells. Gupta, RS, 1985)	0.5
" These adverse effects did not worsen with chronic dosing in monkeys and are consistent with those reported in T-DM1-treated patients to date."	( Preclinical safety profile of trastuzumab emtansine (T-DM1): mechanism of action of its cytotoxic component retained with improved tolerability. Beyer, J; Dybdal, N; Flagella, K; Girish, S; Kaur, S; Poon, KA; Reynolds, T; Saad, O; Tibbitts, J; Yi, JH, 2013)	0.39
" Analyses included adverse events (AEs) by grade; AEs leading to death, drug discontinuation, or dose reduction; and select AEs."	( Trastuzumab emtansine in human epidermal growth factor receptor 2-positive metastatic breast cancer: an integrated safety analysis. Budd, GT; Chernyukhin, N; Diéras, V; Greenson, JK; Guardino, AE; Harbeck, N; Krop, IE; Samant, M; Smitt, MC, 2014)	0.4
"7% of patients experienced grade 3 and 4 adverse events, respectively."	( Feasibility and cardiac safety of trastuzumab emtansine after anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive early-stage breast cancer. Campone, M; Citron, ML; Dang, CT; Dirix, L; Gianni, L; Krop, IE; Romieu, G; Smitt, M; Suter, TM; Xu, N; Zamagni, C, 2015)	0.42
" The objective of this study was to estimate the costs of managing treatment-related grade ≥ 3 adverse events (AEs) that occurred in ≥ 2% of patients and grade 2 AEs that occurred in ≥ 5% of patients taking T-DM1 compared with patients taking CAP + LAP based on the EMILIA trial, from the perspective of Canadian public payers."	( Safety Profile and Costs of Related Adverse Events of Trastuzumab Emtansine for the Treatment of HER2-Positive Locally Advanced or Metastatic Breast Cancer Compared to Capecitabine Plus Lapatinib from the Perspective of the Canadian Health-Care System. Moser, A; Piwko, C; Pollex, E; Prady, C; Yunger, S, 2015)	0.42
" Hepatotoxicity is one of the serious adverse events associated with T-DM1 therapy."	( Ado-Trastuzumab Emtansine Targets Hepatocytes Via Human Epidermal Growth Factor Receptor 2 to Induce Hepatotoxicity. Dokmanovic, M; Endo, Y; Gao, B; Mohan, N; Mukhopadhyay, P; Pacher, P; Rotstein, D; Shen, Y; Wu, WJ; Yan, H, 2016)	0.43
" The most common Grade 3/4 adverse events were thrombocytopenia (22%) and aspartate aminotransferase elevations (14%)."	( A multicenter Phase II study evaluating the efficacy, safety and pharmacokinetics of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive locally recurrent or metastatic breast cancer. Doihara, H; Ito, Y; Kanatani, K; Kashiwaba, M; Masuda, N; Rai, Y; Takao, S; Takashima, S, 2016)	0.43
" Only thrombocytopenia appeared as severe adverse event (grade ≥ 3) in single-arm and control-arm studies."	( Safety and Efficacy of Trastuzumab Emtansine in Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: a Meta-analysis. Jia, H; Ma, X; Shen, K; Wu, X; Zhu, C, 2016)	0.43
"Among 232 patients analyzed, adverse events were reported in 228 patients (98."	( Safety Evaluation of Trastuzumab Emtansine in Japanese Patients with HER2-Positive Advanced Breast Cancer. Ito, Y; Kanatani, K; Masuda, N; Nakagami, K; Nakagawa, S; Nakayama, T; Saeki, T; Takano, T; Takao, S; Tsugawa, K; Watanabe, J, )	0.13
" The study characteristics, details of adverse events (AEs) and details of treatment efficacy were extracted for analysis."	( Safety and efficacy of the addition of pertuzumab to T-DM1 ± taxane in patients with HER2-positive, locally advanced or metastatic breast cancer: a pooled analysis. Li, J; Ma, X; Song, Y; Xia, F; Zhang, J; Zhu, C, 2017)	0.46
" The article also sheds light on factors that may protect the liver from toxic insults."	( Hepatotoxicity with antibody maytansinoid conjugates: A review of preclinical and clinical findings. Bouchard, P; Calise, D; Johnson, R; Kluwe, W; Taplin, S; Vashisht, K; Walles, M, 2018)	0.48
" Adverse events, tumor response, and progression-free survival (PFS) were determined."	( Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Birrer, MJ; Gonzalez-Martin, A; Malek, K; Martin, LP; Moore, KN; O'Malley, DM; Vergote, I, 2018)	0.48
" Adverse events were generally mild (≤ grade 2) with nausea, diarrhea, thrombocytopenia, blurred vision, and fatigue being the most common treatment-emergent toxicities."	( Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Birrer, MJ; Gonzalez-Martin, A; Malek, K; Martin, LP; Moore, KN; O'Malley, DM; Vergote, I, 2018)	0.48
" The adverse event profile was favorable, with a low incidence of grade 3/4 adverse events and no infusion-related reactions."	( A Phase I Study to Assess the Safety and Pharmacokinetics of Single-agent Lorvotuzumab Mertansine (IMGN901) in Patients with Relapsed and/or Refractory CD-56-positive Multiple Myeloma. Ailawadhi, S; Bojanini, L; Chanan-Khan, A; Gharibo, M; Jagannath, S; Kelly, KR; Kirby, M; Sher, T; Vescio, RA; Wolf, J, 2019)	0.51
" Twenty-eight patients (88%) experienced ≥ 1 treatment-related adverse event (AE); the most common AEs were thrombocytopenia (50%) and fatigue (25%)."	( Safety, tolerability, and pharmacokinetics of anti-EGFRvIII antibody-drug conjugate AMG 595 in patients with recurrent malignant glioma expressing EGFRvIII. Cloughesy, T; Curry, R; Damore, MA; Henary, HA; Hill, JS; Rasmussen, E; Reardon, DA; Rosenthal, M; Upreti, VV, 2019)	0.51
" The primary endpoint was a composite of the incidence of T-DM1 treatment modifications secondary to an adverse event."	( Impact of obesity on safety outcomes and treatment modifications with ado-trastuzumab emtansine in breast cancer patients. Larck, C; Lee, A; Moore, DC, 2022)	0.72
" All-grade adverse events with a higher incidence in obese patients included left ventricular ejection fraction decrease (11% vs 5%), bilirubin increase (32% vs 12%), thrombocytopenia (61% vs 55%), and peripheral neuropathy (34% vs 27%)."	( Impact of obesity on safety outcomes and treatment modifications with ado-trastuzumab emtansine in breast cancer patients. Larck, C; Lee, A; Moore, DC, 2022)	0.72
"This study suggests obese patients receiving T-DM1 may require more treatment modifications secondary to adverse events compared to non-obese patients."	( Impact of obesity on safety outcomes and treatment modifications with ado-trastuzumab emtansine in breast cancer patients. Larck, C; Lee, A; Moore, DC, 2022)	0.72
"Human epidermal growth factor receptor 2 (HER2)-targeted therapies improve survival for patients with HER2-positive breast cancer but carry risks of hematologic, cardiopulmonary, gastro-hepatobiliary, and other adverse events (AEs)."	( Incidence of adverse events with therapies targeting HER2-positive metastatic breast cancer: a literature review. Cortes, J; Dang, C; Gilsenan, A; Hackshaw, MD; Layton, JB; Lee, C; Perez, EA; Singh, J; Wang, K, 2022)	0.72
" Understanding the differences in the adverse events (AEs) profile of both drugs may help clinicians make an appropriate treatment decision."	( High risks adverse events associated with trastuzumab emtansine and trastuzumab deruxtecan for the treatment of HER2-positive/mutated malignancies: a pharmacovigilance study based on the FAERS database. Chen, Y; Liu, R; Ma, P; Qi, X; Shi, Q; Tian, H; Zhang, Y, )	0.13
"All data obtained from the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q3 2022 underwent disproportionality analysis and Bayesian analysis to detect and assess the AE signals of T-DM1 and T-DXd for comparison."	( High risks adverse events associated with trastuzumab emtansine and trastuzumab deruxtecan for the treatment of HER2-positive/mutated malignancies: a pharmacovigilance study based on the FAERS database. Chen, Y; Liu, R; Ma, P; Qi, X; Shi, Q; Tian, H; Zhang, Y, )	0.13

Excerpt	Reference	Relevance
" The pharmacokinetic parameters of cantuzumab mertansine, the presence of plasma-shed CanAg, and the development of both human antihuman and human anti-DM1 conjugate antibodies also were characterized."	( Cantuzumab mertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study. Audette, C; Chari, RV; de Bono, J; DeWitte, M; Edwards, T; Hammond, LA; Johnson, R; Jonak, ZL; Lambert, JM; Maes, K; Martino, H; Mays, T; Ochoa, L; Patnaik, A; Rowinsky, EK; Schwartz, G; Smith, L; Takimoto, C; Tolcher, AW, 2003)	0.32
" The mean (+/- SD) clearance and terminal elimination half-life values for cantuzumab mertansine averaged 39."	( Cantuzumab mertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study. Audette, C; Chari, RV; de Bono, J; DeWitte, M; Edwards, T; Hammond, LA; Johnson, R; Jonak, ZL; Lambert, JM; Maes, K; Martino, H; Mays, T; Ochoa, L; Patnaik, A; Rowinsky, EK; Schwartz, G; Smith, L; Takimoto, C; Tolcher, AW, 2003)	0.32
"The humanized monoclonal antibody maytansinoid conjugate, cantuzumab mertansine (huC242-DM1) that contains on average three to four linked drug molecules per antibody molecule was evaluated in CD-1 mice for its pharmacokinetic behavior and tissue distribution, and the results were compared with those of the free antibody huC242."	( Pharmacokinetics and biodistribution of the antitumor immunoconjugate, cantuzumab mertansine (huC242-DM1), and its two components in mice. Audette, C; Blättler, WA; Hoffee, M; Lambert, JM; Xie, H, 2004)	0.32
" Serial serum samples were collected to determine the pharmacokinetic parameters of the prodrug BIWI 1 and of deconjugated BIWI 1 as well as the occurrence of anti-BIWI 1 antibodies."	( Pharmacokinetics, immunogenicity and safety of bivatuzumab mertansine, a novel CD44v6-targeting immunoconjugate, in patients with squamous cell carcinoma of the head and neck. Bogeschdorfer, F; Erhardt, T; Golze, W; Gronau, S; Hoermann, K; Kloft, C; Riechelmann, H; Sauter, A; Schroen, C; Staab, A, 2007)	0.34
" Based on those studies, it was suggested that treatment at intervals of the half-life of the intact immunoconjugate may allow a higher dose density."	( Cantuzumab mertansine in a three-times a week schedule: a phase I and pharmacokinetic study. de Bono, J; Forero, L; Garrison, M; Hammond, LA; Hao, D; Howard, M; Lambert, JM; Pandite, L; Rodon, J; Smith, L; Takimoto, C; Tolcher, AW; Xie, H, 2008)	0.35
" Plasma samples were assayed to determine pharmacokinetic parameters."	( Cantuzumab mertansine in a three-times a week schedule: a phase I and pharmacokinetic study. de Bono, J; Forero, L; Garrison, M; Hammond, LA; Hao, D; Howard, M; Lambert, JM; Pandite, L; Rodon, J; Smith, L; Takimoto, C; Tolcher, AW; Xie, H, 2008)	0.35
" The pharmacokinetic profile of the intact immunoconjugate indicates that the linker is cleaved with a half-life of about 2 days, resulting in faster clearance of the maytansinoid relative to the antibody."	( Cantuzumab mertansine in a three-times a week schedule: a phase I and pharmacokinetic study. de Bono, J; Forero, L; Garrison, M; Hammond, LA; Hao, D; Howard, M; Lambert, JM; Pandite, L; Rodon, J; Smith, L; Takimoto, C; Tolcher, AW; Xie, H, 2008)	0.35
" To determine the pharmacokinetic parameters of anti-CD22-MCC-DM1 and MC-MMAF conjugates, various approaches to quantifying total and conjugated antibody were investigated."	( Anti-CD22-MCC-DM1 and MC-MMAF conjugates: impact of assay format on pharmacokinetic parameters determination. Akutagawa, J; Baudys, J; Bechtel, C; Chan, P; Ebens, A; Elliott, JM; Jacobson, F; Lee, C; Nelson, C; Prabhu, S; Raab, H; Saad, O; Stephan, JP; Vandlen, R; Wong, WL; Xie, D, 2008)	0.35
" Pharmacokinetics data from phase I (n = 52) and phase II (n = 111) studies in HER2-positive metastatic breast cancer patients show a shorter terminal half-life for T-DM1 than for total trastuzumab (TTmAb)."	( Semi-mechanistic population pharmacokinetic model of multivalent trastuzumab emtansine in patients with metastatic breast cancer. Chudasama, VL; Frey, N; Girish, SR; Gupta, M; Harrold, JM; Mager, DE; Schaedeli Stark, F; Tibbitts, J, 2012)	0.38
" An integrated population pharmacokinetic model that simultaneously fits the pharmacokinetics of T-DM1 conjugate and total trastuzumab can help to elucidate the clearance pathways of T-DM1."	( An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer. Burris, HA; Girish, S; Joshi, A; Krop, IE; Lu, D; Olsen, S; Wang, B; Yi, JH, 2013)	0.39
"T-DM1 conjugate and total trastuzumab serum concentration data, including baseline trastuzumab concentrations prior to T-DM1 treatment, from phase I and II studies were used to develop this integrated population pharmacokinetic model."	( An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer. Burris, HA; Girish, S; Joshi, A; Krop, IE; Lu, D; Olsen, S; Wang, B; Yi, JH, 2013)	0.39
" The model fits T-DM1 conjugate and total trastuzumab pharmacokinetic data simultaneously."	( An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer. Burris, HA; Girish, S; Joshi, A; Krop, IE; Lu, D; Olsen, S; Wang, B; Yi, JH, 2013)	0.39
"This semi-mechanistic integrated model links T-DM1 conjugate and total trastuzumab pharmacokinetic data, and supports the inclusion of both proteolytic degradation and deconjugation as clearance pathways in the hypothetical T-DM1 catabolism scheme."	( An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer. Burris, HA; Girish, S; Joshi, A; Krop, IE; Lu, D; Olsen, S; Wang, B; Yi, JH, 2013)	0.39
" A population pharmacokinetic (PK) analysis was performed to estimate typical values and interindividual variability of T-DM1 PK parameters and the effects of clinically relevant covariates."	( Population pharmacokinetics of trastuzumab emtansine (T-DM1), a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer: clinical implications of the effect of covariates. Cobleigh, M; Conte, P; Gao, Y; Girish, S; Guardino, E; Jin, JY; Lu, D; Rimawi, M; Samant, M; Wang, B; Yi, JH, 2014)	0.4
" There were no substantial differences in trastuzumab emtansine or trastuzumab pharmacokinetic parameters between this study and previous data from non-Japanese patients."	( A multicenter Phase II study evaluating the efficacy, safety and pharmacokinetics of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive locally recurrent or metastatic breast cancer. Doihara, H; Ito, Y; Kanatani, K; Kashiwaba, M; Masuda, N; Rai, Y; Takao, S; Takashima, S, 2016)	0.43
"JO22997 results suggest high activity of trastuzumab emtansine in Japanese patients, a safety profile consistent with previous studies in non-Japanese patients, no new safety signals and no evidence of pharmacokinetic differences between Japanese and non-Japanese populations."	( A multicenter Phase II study evaluating the efficacy, safety and pharmacokinetics of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive locally recurrent or metastatic breast cancer. Doihara, H; Ito, Y; Kanatani, K; Kashiwaba, M; Masuda, N; Rai, Y; Takao, S; Takashima, S, 2016)	0.43
" Finally, a systems pharmacokinetic model for intracellular processing of ADCs has been proposed to highlight our current understanding about the determinants of ADC activation inside a cell."	( Evolution of Antibody-Drug Conjugate Tumor Disposition Model to Predict Preclinical Tumor Pharmacokinetics of Trastuzumab-Emtansine (T-DM1). Betts, AM; Khot, A; King, LE; Kulkarni, C; Maass, KF; Shah, DK; Singh, AP; Wittrup, KD, 2016)	0.43
" The pharmacokinetic (PK) data for ado-trastuzumab emtansine point to a faster clearance for the ADC than for total antibody."	( Understanding How the Stability of the Thiol-Maleimide Linkage Impacts the Pharmacokinetics of Lysine-Linked Antibody-Maytansinoid Conjugates. Bogalhas, M; Chari, R; Coccia, J; Erickson, HK; Fishkin, N; Keating, TA; Laleau, R; Lambert, JM; Lanieri, L; Pinkas, J; Ponte, JF; Sun, X; Wang, L; Widdison, W; Wilhelm, S; Yoder, NC, 2016)	0.43
" Mathematical models can be used to study the impact of these processes on overall distribution in an efficient manner, and several types of models have been used to analyze varying aspects of antibody distribution including physiologically based pharmacokinetic (PBPK) models and tissue-level simulations."	( Multiscale Modeling of Antibody-Drug Conjugates: Connecting Tissue and Cellular Distribution to Whole Animal Pharmacokinetics and Potential Implications for Efficacy. Christodolu, N; Cilliers, C; Guo, H; Liao, J; Thurber, GM, 2016)	0.43
" Pharmacokinetic analysis showed that conjugates with an average DAR below ∼6 had comparable clearance rates, but for those with an average DAR of ∼9-10, rapid clearance was observed."	( Effects of Drug-Antibody Ratio on Pharmacokinetics, Biodistribution, Efficacy, and Tolerability of Antibody-Maytansinoid Conjugates. Ab, O; Bogalhas, M; Chari, R; Coccia, J; Dong, L; Erickson, HK; Hong, E; Keating, TA; Laleau, R; Lambert, JM; Lanieri, L; Maloney, EK; Pinkas, J; Ponte, JF; Qiu, Q; Setiady, Y; Sun, X; Wang, L; Wu, R; Yoder, NC; Zhang, X, 2017)	0.46
"We conducted population pharmacokinetic (PopPK) and exposure-response analyses for trastuzumab emtansine (T-DM1), to assess the need for T-DM1 dose optimization in patients with low exposure by using TH3RESA [A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With human epidermal growth factor receptor 2 (HER2)-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy] study data (NCT01419197)."	( Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2-targeted regimens. Chen, SC; French, J; Girish, S; Hoersch, S; Jin, JY; Li, C; Polhamus, D; Quartino, A; Riggs, M; Smitt, M; Strasak, A; Vadhavkar, S; Wang, X, 2017)	0.46
"Systems pharmacokinetic (PK) models that can characterize and predict whole body disposition of antibody-drug conjugates (ADCs) are needed to support (i) development of reliable exposure-response relationships for ADCs and (ii) selection of ADC targets with optimal tumor and tissue expression profiles."	( Development of a Translational Physiologically Based Pharmacokinetic Model for Antibody-Drug Conjugates: a Case Study with T-DM1. Khot, A; Rock, D; Shah, DK; Tibbitts, J, 2017)	0.46
" Pharmacokinetic profiles indicated low levels of circulating unconjugated antibody and cytotoxin, dose-proportional increases in plasma exposures for the conjugated antibody over the studied range, and less than twofold accumulation following multiple Q3W dosing."	( Safety, tolerability, and pharmacokinetics of anti-EGFRvIII antibody-drug conjugate AMG 595 in patients with recurrent malignant glioma expressing EGFRvIII. Cloughesy, T; Curry, R; Damore, MA; Henary, HA; Hill, JS; Rasmussen, E; Reardon, DA; Rosenthal, M; Upreti, VV, 2019)	0.51
" Of which, only first 50 patients were included in pharmacokinetic assessment."	( Comparison of the Efficacy, Safety, Pharmacokinetic and Immunogenicity of UJVIRA (ZRC-3256, Trastuzumab Emtansine) With the Kadcyla (Trastuzumab Emtansine) in the Treatment of HER2-Positive Metastatic Breast Cancer: A Randomized, Open-Label, Multicenter S Batra, U; Chiradoni Thungappa, S; Kumar, S; Maksud, T; Nagarkar, R; Parmar, D; Raut, N, 2022)	0.72
" The pharmacokinetic parameters were comparable between groups."	( Comparison of the Efficacy, Safety, Pharmacokinetic and Immunogenicity of UJVIRA (ZRC-3256, Trastuzumab Emtansine) With the Kadcyla (Trastuzumab Emtansine) in the Treatment of HER2-Positive Metastatic Breast Cancer: A Randomized, Open-Label, Multicenter S Batra, U; Chiradoni Thungappa, S; Kumar, S; Maksud, T; Nagarkar, R; Parmar, D; Raut, N, 2022)	0.72
" An integrated and semi-mechanistic population pharmacokinetic model describing the time-course of all entities in plasma and DAR measurements has been developed."	( Integrated multiple analytes and semi-mechanistic population pharmacokinetic model of tusamitamab ravtansine, a DM4 anti-CEACAM5 antibody-drug conjugate. Chadjaa, M; Fagniez, N; Gibiansky, L; Nguyen, L; Pouzin, C; Tod, M, 2022)	0.72

Excerpt	Reference	Relevance
" The pharmacokinetics (PK), safety, and efficacy of T-DM1 combined with pertuzumab were studied in a phase 1b/2 trial in 67 patients with HER2-positive, locally advanced or metastatic breast cancer (MBC)."	( Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer. Burris, HA; Chu, YW; Cortes, J; Dees, EC; Fang, L; Girish, S; Gupta, M; Joshi, A; Lu, D; Shih, T; Wang, B; Yi, JH, 2012)	0.38
" Because of instability in plasma, further characterization of the DM1 and DM4 intramolecular and intermolecular disulfide conjugates observed in vivo is required before an accurate drug-drug interaction (DDI) prediction can be made."	( In vitro characterization of the drug-drug interaction potential of catabolites of antibody-maytansinoid conjugates. Davis, JA; Pearson, JT; Rock, DA; Wienkers, LC, 2012)	0.38
" These findings suggest that T-DM1 in combination with pertuzumab shows significant antitumor activity by increasing AKT signal inhibition and ADCC in HER2-positive gastric cancers."	( Enhanced antitumor activity of trastuzumab emtansine (T-DM1) in combination with pertuzumab in a HER2-positive gastric cancer model. Fujimoto-Ouchi, K; Harada, N; Shu, S; Yamashita-Kashima, Y, 2013)	0.39
"To determine the maximum tolerated dosage of tucatinib in combination with T-DM1 in the treatment of patients with ERBB2/HER2-positive metastatic breast cancer with and without brain metastases."	( Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. Aucoin, N; Bedard, PL; Borges, VF; Chamberlain, M; Chaves, J; Conlin, A; Falkson, C; Ferrario, C; Gray, T; Hamilton, E; Khan, Q; Krop, I; Vo, A; Welch, S, 2018)	0.48
" Pharmacokinetic analysis showed that there was no drug-drug interaction with T-DM1."	( Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. Aucoin, N; Bedard, PL; Borges, VF; Chamberlain, M; Chaves, J; Conlin, A; Falkson, C; Ferrario, C; Gray, T; Hamilton, E; Khan, Q; Krop, I; Vo, A; Welch, S, 2018)	0.48
"In this study, tucatinib in combination with T-DM1 appeared to have acceptable toxicity and to show preliminary antitumor activity among heavily pretreated patients with ERBB2/HER2-positive metastatic breast cancer with and without brain metastases."	( Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. Aucoin, N; Bedard, PL; Borges, VF; Chamberlain, M; Chaves, J; Conlin, A; Falkson, C; Ferrario, C; Gray, T; Hamilton, E; Khan, Q; Krop, I; Vo, A; Welch, S, 2018)	0.48
"To evaluate the safety profile and preliminary antitumor activity of mirvetuximab soravtansine when administered in combination with carboplatin to relapsed ovarian cancer patients."	( Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Birrer, MJ; Gonzalez-Martin, A; Malek, K; Martin, LP; Moore, KN; O'Malley, DM; Vergote, I, 2018)	0.48
"These data demonstrate that mirvetuximab soravtansine combined with carboplatin is a well-tolerated and highly active regimen in recurrent, platinum-sensitive ovarian cancer."	( Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Birrer, MJ; Gonzalez-Martin, A; Malek, K; Martin, LP; Moore, KN; O'Malley, DM; Vergote, I, 2018)	0.48
"To evaluate the safety and clinical activity of mirvetuximab soravtansine, an antibody-drug conjugate comprising a humanized anti-folate receptor alpha (FRα) monoclonal antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent, in combination with bevacizumab in patients with FRα-positive, platinum-resistant ovarian cancer."	( Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Birrer, MJ; Bratos, R; Castro, CM; Gilbert, L; Malek, K; Mantia-Smaldone, GM; Martin, AG; Martin, LP; Matulonis, UA; Moore, KN; O'Malley, DM; Penson, RT; Vergote, I, 2020)	0.56
" The encouraging efficacy measures compare favorably to reported outcomes for bevacizumab combined with standard chemotherapy in similar patient populations."	( Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Birrer, MJ; Bratos, R; Castro, CM; Gilbert, L; Malek, K; Mantia-Smaldone, GM; Martin, AG; Martin, LP; Matulonis, UA; Moore, KN; O'Malley, DM; Penson, RT; Vergote, I, 2020)	0.56

Excerpt	Reference	Relevance
" The short half-life and low bioavailability of DNA materials due to their interception by the reticuloendothelial system and blood clearance further limit their clinical translation."	( Biomimetic Nanoerythrosome-Coated Aptamer-DNA Tetrahedron/Maytansine Conjugates: pH-Responsive and Targeted Cytotoxicity for HER2-Positive Breast Cancer. Chen, X; Jia, W; Lin, Y; Liu, Z; Ma, W; Yang, Y; Zhang, T; Zhu, J, 2022)	0.97

Excerpt	Relevance	Reference
" Optimization of dosage and schedule of MLN2704 administration defined interdependency between these conditions that maximized efficacy with no apparent toxicity."	( A prostate-specific membrane antigen-targeted monoclonal antibody-chemotherapeutic conjugate designed for the treatment of prostate cancer. Chandra, S; Henry, MD; Milton, M; Silva, MD; Wen, S; Worland, PJ, 2004)	0.32
"5 days and approximately 6-7 days, respectively, for single and repeated dosing after three weeks."	( Pharmacokinetics, immunogenicity and safety of bivatuzumab mertansine, a novel CD44v6-targeting immunoconjugate, in patients with squamous cell carcinoma of the head and neck. Bogeschdorfer, F; Erhardt, T; Golze, W; Gronau, S; Hoermann, K; Kloft, C; Riechelmann, H; Sauter, A; Schroen, C; Staab, A, 2007)	0.34
" MLN2704 is being administered at more frequent intervals in ongoing trials to determine an optimal dosing schedule."	( Phase I trial of the prostate-specific membrane antigen-directed immunoconjugate MLN2704 in patients with progressive metastatic castration-resistant prostate cancer. DeLaCruz, A; Eisenberger, M; Galsky, MD; Kelly, WK; Lee, Y; Moore-Cooper, S; Scher, HI; Slovin, SF; Webb, IJ, 2008)	0.35
" Immunogenicity was evaluated by measuring anti-therapeutic antibodies (ATA) to T-DM1 after repeated dosing using validated bridging antibody electrochemiluminescence or enzyme-linked immunosorbent assays."	( Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Burris Iii, HA; Chu, YW; Girish, S; Gupta, M; Holden, S; Joshi, A; Krop, IE; LoRusso, PM; Lu, D; Saad, O; Tong, B; Vogel, CL; Wang, B; Yi, JH, 2012)	0.38
" Summary statistics of pertuzumab trough and maximal exposure (concentrations at predose and 15-30 minutes after the end of infusion at cycle 1 and at steady state) were similar with those observed in a representative historical single-agent study with the same dosing regimen."	( Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer. Burris, HA; Chu, YW; Cortes, J; Dees, EC; Fang, L; Girish, S; Gupta, M; Joshi, A; Lu, D; Shih, T; Wang, B; Yi, JH, 2012)	0.38
" No accumulation of trastuzumab emtansine or catabolites was observed even after repeated dosing and free DM1 was very low in circulation."	( The success story of trastuzumab emtansine, a targeted therapy in HER2-positive breast cancer. Bachelot, T; Diéras, V, 2014)	0.4
" We have taken examples of ADCs employing either DNA damaging payloads (such as calicheamicin) or tubulin depolymerizing agents (such as auristatins and maytansinoids) to discuss the impact of dose and dosage intervals on pharmacokinetics/pharmacodynamics (PK/PD) and safety of ADCs."	( Preclinical and clinical pharmacokinetic/pharmacodynamic considerations for antibody-drug conjugates. Betts, A; Boni, J; Sapra, P, 2013)	0.39
" These adverse effects did not worsen with chronic dosing in monkeys and are consistent with those reported in T-DM1-treated patients to date."	( Preclinical safety profile of trastuzumab emtansine (T-DM1): mechanism of action of its cytotoxic component retained with improved tolerability. Beyer, J; Dybdal, N; Flagella, K; Girish, S; Kaur, S; Poon, KA; Reynolds, T; Saad, O; Tibbitts, J; Yi, JH, 2013)	0.39
" Continued evaluation of optimal dosing levels and schedules will be important to better define the utility of this promising treatment."	( Lorvotuzumab mertansine: antibody-drug-conjugate for CD56+ multiple myeloma. Berdeja, JG, 2014)	0.4
"To review the pharmacology, pharmacokinetics, efficacy, adverse effects, drug-drug interactions, dosage and administration, and formulary considerations for ado-trastuzumab emtansine."	( Ado-trastuzumab emtansine: a HER2-positive targeted antibody-drug conjugate. Auten, JJ; Cicci, TA; Corrigan, PA; Lowe, DK, 2014)	0.4
" The majority of dosed radioactivity was recovered in feces (~100% of the injected dose over 5 days) with biliary elimination being the predominant route (~46% of the injected dose over 3 days)."	( Non-Clinical Disposition and Metabolism of DM1, a Component of Trastuzumab Emtansine (T-DM1), in Sprague Dawley Rats. Bumbaca, D; Girish, S; Khojasteh, SC; Saad, O; Shen, BQ; Tibbitts, J; Yue, Q, 2015)	0.42
" Dose-response studies in xenograft models demonstrated antitumor activity with both weekly and every-3-weeks dosing regimens."	( Preclinical Efficacy and Safety Assessment of an Antibody-Drug Conjugate Targeting the c-RET Proto-Oncogene for Breast Carcinoma. Arai, T; Armanini, M; Elias, K; Gao, D; Gelmon, K; Haak-Frendscho, M; Kato, J; Landes, G; Leung, S; Miyakawa, S; Mori, T; Nguyen, M; Simmons, AD; Yerushalmi, R, 2015)	0.42
" Optimization of the dosing schedule or an alternate cytotoxic agent with a different mechanism of action may reduce the potential risk of neuropathy."	( Preclinical Efficacy and Safety Assessment of an Antibody-Drug Conjugate Targeting the c-RET Proto-Oncogene for Breast Carcinoma. Arai, T; Armanini, M; Elias, K; Gao, D; Gelmon, K; Haak-Frendscho, M; Kato, J; Landes, G; Leung, S; Miyakawa, S; Mori, T; Nguyen, M; Simmons, AD; Yerushalmi, R, 2015)	0.42
"DS-8201a exhibited a HER2 expression-dependent cell growth-inhibitory activity and induced tumor regression with a single dosing at more than 1 mg/kg in a HER2-positive gastric cancer NCI-N87 model."	( DS-8201a, A Novel HER2-Targeting ADC with a Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising Antitumor Efficacy with Differentiation from T-DM1. Abe, Y; Agatsuma, T; Aida, T; Arakawa, S; Atsumi, R; Hagihara, K; Harada, N; Hayakawa, I; Hirai, T; Ishii, C; Nakada, T; Ogitani, Y; Oitate, M; Okamoto, H; Soma, M; Yamaguchi, J, 2016)	0.43
"These results suggest that T-DM1 pharmacokinetics are comparable across ethnic groups and that use of the current dosing regimen is appropriate across ethnicities."	( Ethnic sensitivity assessment of the antibody-drug conjugate trastuzumab emtansine (T-DM1) in patients with HER2-positive locally advanced or metastatic breast cancer. Chernyukhin, N; Gao, Y; Girish, S; Igawa, Y; Jin, JY; Li, C; Lu, D; Lu, M; Matsunaga, K; Nijem, I; Strasak, A; Wang, B, 2016)	0.43
" After repeated dosing (three cycles), T-DM1 exposure in patients with mild and moderate hepatic impairment was within the range seen in those with normal hepatic function."	( A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function. Agarwal, P; Chernyukhin, N; Dent, S; Gibiansky, E; Girish, S; Gonçalves, A; Harle-Yge, ML; Jin, JY; Li, C; LoRusso, P; Nijem, I; Strasak, A, 2017)	0.46
" However, the model suggested that a fractionated dosing regimen (e."	( Application of a PK-PD Modeling and Simulation-Based Strategy for Clinical Translation of Antibody-Drug Conjugates: a Case Study with Trastuzumab Emtansine (T-DM1). Shah, DK; Singh, AP, 2017)	0.46
" The administration dosage or schedule of T-DM1 was modified based on laboratory tests on the administration day."	( Safety Evaluation of Trastuzumab Emtansine in Japanese Patients with HER2-Positive Advanced Breast Cancer. Ito, Y; Kanatani, K; Masuda, N; Nakagami, K; Nakagawa, S; Nakayama, T; Saeki, T; Takano, T; Takao, S; Tsugawa, K; Watanabe, J, )	0.13
" No meaningful drug accumulation was observed with the dosing regimen of once every 3 weeks."	( Phase 1 dose-escalation study of mirvetuximab soravtansine (IMGN853), a folate receptor α-targeting antibody-drug conjugate, in patients with solid tumors. Bauer, TM; Birrer, MJ; Borghaei, H; Jeong, W; Matulonis, UA; Moore, KN; O'Malley, DM; Perez, RP; Ponte, JF; Ruiz-Soto, R; Running, KL; Seward, SM; Zhang, X, 2017)	0.46
"To determine the maximum tolerated dosage of tucatinib in combination with T-DM1 in the treatment of patients with ERBB2/HER2-positive metastatic breast cancer with and without brain metastases."	( Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. Aucoin, N; Bedard, PL; Borges, VF; Chamberlain, M; Chaves, J; Conlin, A; Falkson, C; Ferrario, C; Gray, T; Hamilton, E; Khan, Q; Krop, I; Vo, A; Welch, S, 2018)	0.48
" The tucatinib maximum tolerated dosage was determined to be 300 mg administered twice per day with dose-limiting toxic reactions seen at 350 mg twice per day."	( Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. Aucoin, N; Bedard, PL; Borges, VF; Chamberlain, M; Chaves, J; Conlin, A; Falkson, C; Ferrario, C; Gray, T; Hamilton, E; Khan, Q; Krop, I; Vo, A; Welch, S, 2018)	0.48
"Eighteen patients were enrolled and dosed with combination therapy; thirteen continued with mirvetuximab soravtansine maintenance following carboplatin discontinuation."	( Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Birrer, MJ; Gonzalez-Martin, A; Malek, K; Martin, LP; Moore, KN; O'Malley, DM; Vergote, I, 2018)	0.48
"Preclinical modeling was predictive of the corneal-related symptoms seen in some patients dosed with mirvetuximab soravtansine."	( Evaluation of Prophylactic Corticosteroid Eye Drop Use in the Management of Corneal Abnormalities Induced by the Antibody-Drug Conjugate Mirvetuximab Soravtansine. Bauer, TM; Birrer, MJ; Gilbert, L; Kim, SK; Konner, J; Malek, K; Martin, LP; Matulonis, UA; Moore, KN; O'Malley, DM; Oza, AM; Pinkas, J, 2019)	0.51
"In this phase 1, first-in-human, open-label, sequential-dose, exploration study, adults with recurrent GBM received AMG 595 once every 3 weeks (Q3W) according to incremental dosing cohorts (0."	( Safety, tolerability, and pharmacokinetics of anti-EGFRvIII antibody-drug conjugate AMG 595 in patients with recurrent malignant glioma expressing EGFRvIII. Cloughesy, T; Curry, R; Damore, MA; Henary, HA; Hill, JS; Rasmussen, E; Reardon, DA; Rosenthal, M; Upreti, VV, 2019)	0.51
" When dosed at MTD, SAMPDs inhibited primary tumor growth and pulmonary metastasis by 80% and 95%, while mertansine dosed at MTD only reduced primary tumor growth and metastasis by <50% and 60%, respectively."	( Self-assembling mertansine prodrug improves tolerability and efficacy of chemotherapy against metastatic triple-negative breast cancer. Cai, Y; Chang, L; Li, Y; Liu, J; Liu, X; Ran, W; Zhang, P; Zheng, C, 2020)	0.56
"Sixty-six patients, with a median of 3 prior lines of therapy (range, 1-8), received the combination of mirvetuximab soravtansine and bevacizumab at full dosing during the escalation and expansion stages of the study."	( Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Birrer, MJ; Bratos, R; Castro, CM; Gilbert, L; Malek, K; Mantia-Smaldone, GM; Martin, AG; Martin, LP; Matulonis, UA; Moore, KN; O'Malley, DM; Penson, RT; Vergote, I, 2020)	0.56
" The 2012 American Society of Clinical Oncology guidelines on chemotherapy dosing in obesity recommend using full weight-based cytotoxic chemotherapy doses to treat obese patients with cancer."	( Impact of obesity on safety outcomes and treatment modifications with ado-trastuzumab emtansine in breast cancer patients. Larck, C; Lee, A; Moore, DC, 2022)	0.72
" Comparison of BSA-adjusted dosing and flat dosing supported the current BSA-based dosing regimen, to limit under and over exposure in patients with extreme BSA."	( Covariate analysis of tusamitamab ravtansine, a DM4 anti-CEACAM5 antibody-drug conjugate, based on first-in-human study. Chadjaa, M; Fagniez, N; Nguyen, L; Pouzin, C; Tod, M, 2022)	0.72

Role	Description
plant metabolite	Any eukaryotic metabolite produced during a metabolic reaction in plants, the kingdom that include flowering plants, conifers and other gymnosperms.
antimicrobial agent	A substance that kills or slows the growth of microorganisms, including bacteria, viruses, fungi and protozoans.
antineoplastic agent	A substance that inhibits or prevents the proliferation of neoplasms.
tubulin modulator	Any substance that interacts with tubulin to inhibit or promote polymerisation of microtubules.
antimitotic	Any compound that inhibits cell division (mitosis).
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Class	Description
epoxide	Any cyclic ether in which the oxygen atom forms part of a 3-membered ring.
carbamate ester	Any ester of carbamic acid or its N-substituted derivatives.
organochlorine compound	An organochlorine compound is a compound containing at least one carbon-chlorine bond.
alpha-amino acid ester	The amino acid ester derivative obtained the formal condensation of an alpha-amino acid with an alcohol.
organic heterotetracyclic compound
maytansinoid	Any member of the group of 19-membered lactams that is maytansine or structurally related to it. Maytansinoids have been isolated from members of the higher plant families Celastraceae, Rhamnaceae, and Euphorbiaceae, as well as some mosses and certain Actinomycetes, but the term is used to cover both naturally occurring compounds and their semisynthetic derivatives.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Assay ID	Title	Year	Journal	Article
AID1131579	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 6.2 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID267449	Cytotoxicity against human KB cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID267452	Cytotoxicity against human A549 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID1131595	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 25 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131554	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 100 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID44202	Effect on cross resistance of CCRF-CEM cells resistant to vincristine.	1990	Journal of medicinal chemistry, Jul, Volume: 33, Issue:7	Structure-activity relationships of antineoplastic agents in multidrug resistance.
AID1131543	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 0.8 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131561	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 0.8 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID335777	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 0.0064 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID1131557	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 12.5 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131583	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 0.4 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131581	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 1.6 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID267453	Cytotoxicity against human Ovcar3 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID1131555	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 50 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131573	Inhibition of brain tubulin polymerization (unknown origin) at 37 degC by spectrophotometry	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID335773	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 4 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID1131572	Cytotoxicity against human KB cells	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131576	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 100 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131544	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 0.4 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131597	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 6.2 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131559	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 3.1 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID333842	Cytotoxicity against human KB cells
AID1131558	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 6.2 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131593	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 100 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131541	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 3.1 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID267457	Cytotoxicity against human A375 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID267454	Cytotoxicity against human SW620 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID1131575	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 50 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131580	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 3.1 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID335775	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 0.16 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID335774	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 0.8 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID335776	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 0.032 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID1131560	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 1.6 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID335771	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 100 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID267451	Cytotoxicity against human A431 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID23271	Partition coefficient (logD7.4)	1990	Journal of medicinal chemistry, Jul, Volume: 33, Issue:7	Structure-activity relationships of antineoplastic agents in multidrug resistance.
AID1131556	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 25 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID267456	Cytotoxicity against human MCF7 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID1131596	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 12.5 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131582	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 0.8 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131594	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 50 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131574	Antimitotic activity against sea urchin eggs assessed as drug level causing inhibition of mitosis	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID1131542	Toxicity in PS mouse allografted with mouse P388 cells assessed as change in body weight at 1.6 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID335778	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 0.00128 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID335772	Antimitotic activity in rat ASK cells assessed as reversal of astrocyte formation at 20 ug/mL	1993	Journal of natural products, Oct, Volume: 56, Issue:10	Cytotoxic constituents from Hyptis verticillata.
AID1131578	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 12.5 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID267455	Cytotoxicity against human HCT15 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID267450	Cytotoxicity against human SK-Br-3 cell line by clonogenic plating efficiency assay after 72 hrs	2006	Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14	Semisynthetic maytansine analogues for the targeted treatment of cancer.
AID397122	Inhibition of HIV1 RT
AID1131562	Antitumor activity against mouse P388 cells allografted in PS mouse assessed as median survival time at 0.4 ug/kg relative to control	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
AID99173	Cross resistance profile versus L1210/R71 cells.	1990	Journal of medicinal chemistry, Jul, Volume: 33, Issue:7	Structure-activity relationships of antineoplastic agents in multidrug resistance.
AID1131577	Toxicity in PS mouse allografted with mouse P388 cells assessed as survival at 25 ug/kg after 4 days	1978	Journal of medicinal chemistry, Jan, Volume: 21, Issue:1	Structural requirements for antileukemic activity among the naturally occurring and semisynthetic maytansinoids.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	92 (11.72)	18.7374
1990's	24 (3.06)	18.2507
2000's	62 (7.90)	29.6817
2010's	482 (61.40)	24.3611
2020's	125 (15.92)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	96 (11.78%)	5.53%
Reviews	125 (15.34%)	6.00%
Case Studies	40 (4.91%)	4.05%
Observational	4 (0.49%)	0.25%
Other	550 (67.48%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (130)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression [NCT04296890]	Phase 3	106 participants (Actual)	Interventional	2020-07-23	Completed
A Single-arm, Phase III Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Advanced High-grade Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer With High Expression of Folate Receptor-α [NCT05622890]	Phase 3	35 participants (Anticipated)	Interventional	2022-08-18	Recruiting
Molecular Analysis for Therapy Choice (MATCH) [NCT02465060]	Phase 2	6,452 participants (Anticipated)	Interventional	2015-08-17	Active, not recruiting
Open-label, Phase 2 Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metast [NCT05849246]	Phase 2	130 participants (Anticipated)	Interventional	2023-05-30	Not yet recruiting
An Open-label, Multicenter Rollover Study to Provide Continued Treatment With Anetumab Ravtansine for Participants With Solid Tumors Who Were Enrolled in Previous Bayer-sponsored Studies [NCT03926143]	Phase 2	9 participants (Actual)	Interventional	2019-06-03	Terminated(stopped due to Due to strategic company decisions, the development of anetumab ravtansine was stopped.)
An Open-label, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343), an Anti-mesothelin Antibody Drug Conjugate, in Pretreated Mesothelin-expressing Advanced Pancreatic Cancer [NCT03023722]	Phase 2	18 participants (Actual)	Interventional	2017-05-11	Completed
A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; NSC#: 783609) in Children With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma [NCT02452554]	Phase 2	62 participants (Actual)	Interventional	2015-10-12	Completed
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Br [NCT04740918]	Phase 3	96 participants (Anticipated)	Interventional	2021-06-07	Active, not recruiting
Phase II, Exploratory, Multicenter, Non Randomized, Single Agent Cohort Study to Determine Best Tumor Response With Trastuzumab Emtansine in HER2 Overexpressing Solid Tumors [NCT02999672]	Phase 2	20 participants (Actual)	Interventional	2016-12-23	Completed
Women's Triple-Negative First-Line Study: A Phase II Trial of Mirvetuximab Soravtansine in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NACT), Including a Lead-In Coho [NCT03106077]	Phase 2	96 participants (Actual)	Interventional	2017-06-05	Completed
A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment [NCT01702571]	Phase 3	2,185 participants (Actual)	Interventional	2012-11-27	Completed
MATCH Treatment Subprotocol Q: Ado-trastuzumab Emtansine in Patients With Tumors With HER2 Amplification (Except Breast and Gastric/Gastro-Esophageal Junction (GEJ) Adenocarcinomas) [NCT04439110]	Phase 2	38 participants (Actual)	Interventional	2015-08-12	Active, not recruiting
An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit [NCT02254018]	Phase 1	31 participants (Actual)	Interventional	2002-09-01	Completed
A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Po [NCT01966471]	Phase 3	1,846 participants (Actual)	Interventional	2014-01-31	Completed
A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas [NCT04620187]	Phase 2	55 participants (Anticipated)	Interventional	2020-12-24	Recruiting
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Ca [NCT02924883]	Phase 2	202 participants (Actual)	Interventional	2016-09-26	Completed
An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus With Repeated Administration Courses in Patients W [NCT02254044]	Phase 1	7 participants (Actual)	Interventional	2003-10-31	Terminated
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME [NCT03878524]	Phase 1	2 participants (Actual)	Interventional	2020-04-01	Active, not recruiting
Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies [NCT03102320]	Phase 1	173 participants (Actual)	Interventional	2017-05-26	Completed
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib [NCT05323955]	Phase 2	48 participants (Anticipated)	Interventional	2023-03-23	Recruiting
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT) [NCT05238831]	Early Phase 1	25 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer With Repeated Administration Courses in Patients With Cl [NCT02254031]	Phase 1	8 participants (Actual)	Interventional	2003-07-01	Terminated
An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration in Patients With Clinical Benefit [NCT02254005]	Phase 1	24 participants (Actual)	Interventional	2002-10-01	Completed
A Phase II Trial of HKI-272 (Neratinib), Neratinib and Capecitabine, and Ado-Trastuzumab Emtansine for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases [NCT01494662]	Phase 2	140 participants (Actual)	Interventional	2012-02-29	Active, not recruiting
Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes [NCT03894007]	Phase 2	6 participants (Actual)	Interventional	2019-05-23	Terminated(stopped due to Security and effect data from another ongoing study.)
Open-label, Phase II Study of Trastuzumab Emtansine in Patients With HER2-positive Metastatic Colorectal Cancer Progressing After Trastuzumab and Lapatinib: HERACLES RESCUE. (HER2 Amplification for Colo-rectaL Cancer Enhanced Stratification - REchallenge [NCT03418558]	Phase 2	13 participants (Anticipated)	Interventional	2015-07-08	Recruiting
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy [NCT04591431]	Phase 2	400 participants (Actual)	Interventional	2020-10-07	Active, not recruiting
A Phase 1b Trial of Sequential Combinations of BN-Brachyury, Entinostat, Ado-trastuzuamb Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) [NCT04296942]	Phase 1	1 participants (Actual)	Interventional	2021-05-04	Terminated(stopped due to One participant was accrued, and the study was stopped due to new safety data from the company for M7824 and slow accrual.)
Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and Pembrolizumab (MK-3475) Compared to Pembrolizumab Alone for Mesothelin-Positive Malignant Pleural Mesothelioma [NCT03126630]	Phase 1/Phase 2	46 participants (Actual)	Interventional	2018-10-04	Active, not recruiting
A Phase II, Open-Label Study to Evaluate Corrected QT Interval Effects of Trastuzumab-MCC-DM1 (T-DM1) in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer and to Evaluate the Safety and Tolerability of Combined T-DM1 and Pertuzumab [NCT00943670]	Phase 2	51 participants (Actual)	Interventional	2009-07-31	Completed
An Open-Label, Multi-Center Phase I/II Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer [NCT00934856]	Phase 1/Phase 2	98 participants (Actual)	Interventional	2009-07-31	Completed
A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin, in Adults With [NCT02606305]	Phase 1/Phase 2	264 participants (Actual)	Interventional	2015-12-31	Completed
A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine in Indian Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane [NCT02658734]	Phase 4	70 participants (Actual)	Interventional	2016-11-01	Completed
Phase II Trial With Safety Run-in of the Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma [NCT02839681]	Phase 2	2 participants (Actual)	Interventional	2016-07-19	Terminated(stopped due to Due to slow, insufficient accrual.)
A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy [NCT06126640]	Phase 3	1,200 participants (Anticipated)	Interventional	2023-11-30	Not yet recruiting
Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors [NCT05429762]	Phase 1	56 participants (Actual)	Interventional	2022-10-03	Active, not recruiting
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically [NCT01772472]	Phase 3	1,487 participants (Actual)	Interventional	2013-04-03	Active, not recruiting
A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Plati [NCT02610140]	Phase 2	248 participants (Actual)	Interventional	2015-12-03	Completed
A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (PICCOLO) [NCT05041257]	Phase 2	79 participants (Actual)	Interventional	2021-08-31	Active, not recruiting
A Phase II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy [NCT00509769]	Phase 2	112 participants (Actual)	Interventional	2007-07-31	Completed
Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Exp [NCT04524689]	Phase 2	215 participants (Anticipated)	Interventional	2020-10-26	Recruiting
KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II [NCT05525858]		1,000 participants (Anticipated)	Observational	2022-09-28	Recruiting
Phase I Study of Mirvetuximab Soravtansine (IMGN853) and Rucaparib for Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer [NCT03552471]	Phase 1	25 participants (Actual)	Interventional	2018-07-12	Active, not recruiting
A Phase II, Single-Arm, Open-Label Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer [NCT00679211]	Phase 2	110 participants (Actual)	Interventional	2008-08-31	Completed
A Phase Ib-IIa, Open-label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of Trastuzumab Emtansine, Paclitaxel and Pertuzumab Administered Intravenously to Patients With Her2-positive, Locally Advanced or Metastatic Breast Cancer [NCT00951665]	Phase 1/Phase 2	107 participants (Actual)	Interventional	2009-08-31	Completed
An Open-label Phase Ib Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Maximum Tolerated Dose of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin 30 mg/m2 Given Every 3 Weeks in Subje [NCT02751918]	Phase 1	65 participants (Actual)	Interventional	2016-06-08	Completed
A Phase I Dose-Escalation Safety and Tolerability Study of MirvetuximabSoravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) [NCT02996825]	Phase 1	44 participants (Actual)	Interventional	2017-03-22	Active, not recruiting
A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers [NCT02675829]	Phase 2	140 participants (Anticipated)	Interventional	2016-02-29	Recruiting
An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Anetumab Ravtansine in Subjects With Mesothelin-expressing Advanced Solid Cancers and Different Stages of Concurrent Hepatic or Renal Impairment [NCT02696642]	Phase 1	54 participants (Actual)	Interventional	2016-04-14	Completed
A Phase Ib/II, Open-label Study of the Safety, Tolerability, and Efficacy of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Posi [NCT00875979]	Phase 1/Phase 2	67 participants (Actual)	Interventional	2009-05-31	Completed
An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin, Perjeta in Combination With Herceptin, or Kadcyla During Pregnancy or Within 7 Months Prior to Conception [NCT00833963]		20 participants (Actual)	Observational [Patient Registry]	2009-01-14	Completed
A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors [NCT04931342]	Phase 2	550 participants (Anticipated)	Interventional	2021-10-07	Recruiting
Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA [NCT05245071]	Phase 2	38 participants (Anticipated)	Interventional	2022-06-03	Recruiting
A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Ther [NCT00829166]	Phase 3	991 participants (Actual)	Interventional	2009-02-28	Completed
An Open Label, Phase I Study to Assess the Effect of Itraconazole (CYP3A4 and P-gp Inhibitor) on the Pharmacokinetics of Anetumab Ravtansine and to Assess the ECG Effects, Safety and Immunogenicity of Anetumab Ravtansine Given as a Single Agent and Togeth [NCT02824042]	Phase 1	63 participants (Actual)	Interventional	2016-09-07	Completed
A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine [NCT02226276]		10 participants (Actual)	Interventional	2015-01-07	Active, not recruiting
A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Lin [NCT01120184]	Phase 3	1,095 participants (Actual)	Interventional	2010-07-31	Completed
A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive Breast C [NCT02605915]	Phase 1	98 participants (Anticipated)	Interventional	2015-12-31	Completed
Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy [NCT05754502]		300 participants (Anticipated)	Observational	2021-07-27	Recruiting
A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial) [NCT01853748]	Phase 2	512 participants (Actual)	Interventional	2013-05-31	Active, not recruiting
Phase I/II Study of the Human Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine (AR), Combined With the PD-L1 Inhibitor Atezolizumab in Non-Small Cell Lung Cancer [NCT03455556]	Phase 1	1 participants (Actual)	Interventional	2018-08-10	Terminated(stopped due to slow accrual)
An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients With HER2-Positive Solid Tumors [NCT04189211]	Phase 1	30 participants (Anticipated)	Interventional	2017-03-07	Active, not recruiting
A Feasibility Study of De-escalation of Chemotherapy in Patients With Early-Stage HER2 Positive Breast Cancer [NCT04419181]	Phase 2	20 participants (Anticipated)	Interventional	2024-08-11	Suspended(stopped due to Change in the landscape of current treatment of early stage breast cancer. Larger clinical trials answering similar questions are expected to result in the next few years.)
A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer [NCT05887609]	Phase 2	53 participants (Anticipated)	Interventional	2023-10-03	Recruiting
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment. [NCT01975142]	Phase 2	155 participants (Actual)	Interventional	2013-11-07	Completed
A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naive, Unresectable HER2-Positive Salivary Gland Cancer [NCT05408845]	Phase 2	116 participants (Anticipated)	Interventional	2022-09-30	Recruiting
MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor- [NCT04209855]	Phase 3	453 participants (Actual)	Interventional	2019-12-31	Active, not recruiting
A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metasta [NCT00679341]	Phase 2	137 participants (Actual)	Interventional	2008-09-30	Completed
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer [NCT04924699]	Phase 2/Phase 3	350 participants (Anticipated)	Interventional	2021-06-30	Recruiting
Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer [NCT02725541]	Phase 2	0 participants (Actual)	Interventional	2016-03-31	Withdrawn(stopped due to loss of funding support)
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Can [NCT03529110]	Phase 3	524 participants (Actual)	Interventional	2018-08-09	Active, not recruiting
A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Ca [NCT01196052]	Phase 2	153 participants (Actual)	Interventional	2010-10-31	Completed
A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer [NCT05755048]	Phase 3	314 participants (Anticipated)	Interventional	2023-03-28	Recruiting
A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer [NCT05650879]	Phase 1	178 participants (Anticipated)	Interventional	2023-03-20	Recruiting
A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0) [NCT04893109]	Phase 2	500 participants (Anticipated)	Interventional	2021-06-16	Recruiting
The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib [NCT04457596]	Phase 3	1,031 participants (Anticipated)	Interventional	2021-01-06	Recruiting
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB) [NCT05673928]	Phase 2	30 participants (Anticipated)	Interventional	2023-05-16	Recruiting
FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Prim [NCT02631876]	Phase 3	366 participants (Actual)	Interventional	2016-03-02	Completed
Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity - DARWINII [NCT02314481]	Phase 2	50 participants (Actual)	Interventional	2017-05-12	Active, not recruiting
De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade [NCT04675827]	Phase 2	1,065 participants (Anticipated)	Interventional	2022-01-17	Suspended(stopped due to Serious concerns on the slow recruitment of the study that impacts the robustness of the scientific rationale and the study financial provision. It aims to assess carefully the situation and to evaluate the potential solutions to overcome the issues.)
Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer [NCT03836157]	Phase 2	0 participants (Actual)	Interventional	2019-05-31	Withdrawn(stopped due to Study was not initiated.)
Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial [NCT04589845]	Phase 2	920 participants (Anticipated)	Interventional	2021-01-18	Recruiting
A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer [NCT04486352]	Phase 1/Phase 2	148 participants (Anticipated)	Interventional	2021-10-20	Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Ear [NCT03726879]	Phase 3	454 participants (Actual)	Interventional	2019-01-11	Completed
A Phase lb/ll, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Lo [NCT04298918]	Phase 1/Phase 2	1 participants (Actual)	Interventional	2020-09-23	Terminated(stopped due to Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the CO41863 study.)
A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function [NCT01513083]	Phase 1	28 participants (Actual)	Interventional	2012-02-29	Completed
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction: A Randomized, Controlled Trial [NCT04680442]	Phase 2	130 participants (Anticipated)	Interventional	2021-07-01	Recruiting
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling [NCT04341181]	Phase 2	300 participants (Anticipated)	Interventional	2020-08-24	Recruiting
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors [NCT05593094]	Phase 1	210 participants (Anticipated)	Interventional	2020-10-15	Recruiting
A Phase Ib/II Study of Pembrolizumab and Monoclonal Antibody Therapy in Patients With Advanced Cancer (PembroMab [NCT02318901]	Phase 1/Phase 2	16 participants (Actual)	Interventional	2014-10-31	Terminated(stopped due to PI no longer at sight. Results not collected)
An Observational Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Second- or Later-Line Therapy in Chinese Patients With HER2 Positive Advanced Breast Cancer [NCT05945927]		500 participants (Anticipated)	Observational	2023-09-13	Recruiting
Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or [NCT05445778]	Phase 3	418 participants (Anticipated)	Interventional	2022-12-27	Recruiting
Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors [NCT05071053]	Phase 2	35 participants (Actual)	Interventional	2021-11-16	Active, not recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Th [NCT04873362]	Phase 3	1,700 participants (Anticipated)	Interventional	2021-05-04	Recruiting
"Phase Ib Clinical Trial of Copanlisib in Combination With Trastuzumab Emtansine (T-DM1) in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer Panthera" [NCT04042051]	Phase 1	2 participants (Actual)	Interventional	2019-11-12	Terminated(stopped due to Accrual rate to date was too low to finish the trial in a reasonable timeframe)
Phase II Trial to Evaluate Immune-Related Biomarkers for Pathological Response in Stage II-III HER2-Positive Breast Cancer Receiving Neoadjuvant Chemotherapy With Subsequent Randomization to Multi-Epitope HER2 Vaccine vs. Placebo in Patients With Residual [NCT04197687]	Phase 2	480 participants (Anticipated)	Interventional	2020-02-20	Recruiting
MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response [NCT04632992]	Phase 2	252 participants (Actual)	Interventional	2021-01-13	Active, not recruiting
Multicenter, Open-label, ph 2 Study of Carboplatin Plus Mirvetuximab Soravtansine Followed by Mirvetuximab Soravtansine Continuation in FRα Positive, Recurrent Platinum-sensitive, High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer [NCT05456685]	Phase 2	114 participants (Anticipated)	Interventional	2022-09-28	Recruiting
Thrombokinetic Studies of Ado-Trastuzumab Emtansine [NCT01816035]	Phase 1	13 participants (Actual)	Interventional	2014-06-30	Completed
An Open Label Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose of the Anti-mesothelin Antibody Drug Conjugate BAY94-9343 in Subjects With Advanced Solid Tumors [NCT01439152]	Phase 1	148 participants (Actual)	Interventional	2011-09-07	Completed
An Open-label Phase II Study of Lorvotuzumab Mertansine (IMGN901) in CD56 Expressing Hematological Malignancies [NCT02420873]	Phase 2	9 participants (Actual)	Interventional	2015-05-12	Completed
A Prospective, Multicenter，Phase II Clinical Study of Trastuzumab and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy [NCT05560308]		50 participants (Anticipated)	Interventional	2022-09-30	Not yet recruiting
A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab Emtansine Versus Lapatinib Plus Capecitabine in Chinese Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastu [NCT03084939]	Phase 3	351 participants (Actual)	Interventional	2017-04-24	Completed
INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701 [NCT05703555]	Phase 2	60 participants (Anticipated)	Interventional	2023-02-28	Not yet recruiting
Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors [NCT04659603]	Phase 2	94 participants (Anticipated)	Interventional	2021-03-29	Recruiting
An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emta [NCT00781612]	Phase 2	720 participants (Anticipated)	Interventional	2008-10-16	Recruiting
A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Ca [NCT01641939]	Phase 2/Phase 3	415 participants (Actual)	Interventional	2012-09-03	Terminated
A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Adv [NCT05415215]	Phase 3	330 participants (Anticipated)	Interventional	2022-07-05	Active, not recruiting
A Phase I Study of Anetumab Ravtansine in Combination With Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma [NCT03816358]	Phase 1	74 participants (Anticipated)	Interventional	2019-12-09	Active, not recruiting
Open-Label, Phase II Study of Trastuzumab in Combination With Lapatinib (Cohort A) or Pertuzumab in Combination With Trastuzumab-emtansine (Cohort B) in Patients With HER2-positive Metastatic Colorectal Cancer: the HERACLES (HER2 Amplification for Colo-re [NCT03225937]	Phase 2	54 participants (Anticipated)	Interventional	2012-08-31	Active, not recruiting
Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRα)-Expressing, Triple Negative Breast Cancer (TNBC) With Residual Disease Post Standard Neoadjuvant Chemotherapy [NCT03045393]	Phase 1	0 participants (Actual)	Interventional	2017-04-17	Withdrawn(stopped due to Inadequate enrollment)
(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response [NCT04266249]	Phase 2	2,156 participants (Anticipated)	Interventional	2020-03-13	Recruiting
A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Reg [NCT01419197]	Phase 3	602 participants (Actual)	Interventional	2011-09-30	Completed
Phase II Trial of Abemaciclib and T-DM1 in Women and Men With HER2-positive Advanced or Metastatic Breast Cancer Who Progressed on Treatment With a Taxane, Trastuzumab and Pertuzumab [NCT04351230]	Phase 2	0 participants (Actual)	Interventional	2020-11-11	Withdrawn(stopped due to There are no patients enrolled on this study and all efforts are being discontinued)
A Phase 1B Dose Escalation Trial of Human Anti 4 1BB Agonistic Antibody Utomilumab (PF 05082566) in Combination With Ado Trastuzumab Emtansine or Trastuzumab in Patients With HER2 Postive Advanced Breast Cancer [NCT03364348]	Phase 1	18 participants (Actual)	Interventional	2017-10-30	Completed
A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors [NCT01609556]	Phase 1	206 participants (Actual)	Interventional	2012-06-28	Completed
Trastuzumab-emtansine and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC [NCT03784599]	Phase 2	28 participants (Actual)	Interventional	2018-12-18	Terminated(stopped due to insufficient effectiveness)
Phase I Study of the Combination of Trastuzumab Emtansine (T-DM1) and Capecitabine in HER2-Positive Metastatic Breast Cancer and HER2-Positive Locally Advanced/Metastatic Gastric Cancer Patients, Followed by a Randomized, Open-Label Phase II Study of Tras [NCT01702558]	Phase 2	182 participants (Actual)	Interventional	2012-12-03	Terminated(stopped due to The sponsor decided to terminate study after 70% of participants had experienced a progression-free survival event.)
SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function [NCT01904903]	Phase 2	31 participants (Actual)	Interventional	2013-10-31	Completed
Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study [NCT06125834]	Phase 2	36 participants (Anticipated)	Interventional	2023-06-01	Recruiting
A Randomized Phase II Trial of Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer Eligible for Platinum-based Chemotherapy. Supported by: DIAGNOSTIC PROTOCOL for the VENTANA FOLR1 (FOLR1-2.1) CDx Assay Ventan [NCT04274426]	Phase 2	136 participants (Anticipated)	Interventional	2021-10-13	Recruiting
A Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian Cancer [NCT03587311]	Phase 2	96 participants (Anticipated)	Interventional	2018-10-12	Active, not recruiting
A Phase I/II Study to Evaluate the Safety and Efficacy of Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer [NCT02658084]	Phase 1/Phase 2	2 participants (Actual)	Interventional	2017-04-12	Terminated(stopped due to Terminated due to low accrual and toxicity concerns.)
A Phase I Study of Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Patients With Logically Advanced Inoperable or Metastatic HER2-Positive Breast Cancer Who Have Received Prior Trastuzumab Based Therapy [NCT03153163]	Phase 1	11 participants (Actual)	Interventional	2017-06-20	Completed
A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer [NCT02131064]	Phase 3	444 participants (Actual)	Interventional	2014-06-25	Completed
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel as First-Line Treatment of Patients With Her2-Positive Progressive Or Recurrent Locally [NCT02144012]	Phase 3	49 participants (Actual)	Interventional	2014-06-30	Terminated
A Phase I Study of BYL719 and Trastuzumab-MCC-DM1 in HER2-Positive Metastatic Breast Cancer Patients With Progression on Prior Trastuzumab and Taxane-Based Therapy [NCT02038010]	Phase 1	17 participants (Actual)	Interventional	2014-05-21	Completed
Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Are Folate Receptor α Positive [NCT04606914]	Phase 2	70 participants (Anticipated)	Interventional	2021-05-27	Recruiting
Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer [NCT02390427]	Phase 1	68 participants (Actual)	Interventional	2015-04-20	Active, not recruiting
A Phase 2, Multicenter, Single-Arm Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Received At Least One Prior Chemotherapy Regimen [NCT02289833]	Phase 2	49 participants (Actual)	Interventional	2014-12-15	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00509769 (6) [back to overview]	Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00509769 (6) [back to overview]	Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00509769 (6) [back to overview]	Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00509769 (6) [back to overview]	Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00509769 (6) [back to overview]	Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00509769 (6) [back to overview]	Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00679211 (8) [back to overview]	Progression-free Survival as Assessed Through Independent Radiologic Review
NCT00679211 (8) [back to overview]	Percentage of Participants With Clinical Benefit Based on Investigator Assessment
NCT00679211 (8) [back to overview]	Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review
NCT00679211 (8) [back to overview]	Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review
NCT00679211 (8) [back to overview]	Objective Response Based on Investigator Assessment
NCT00679211 (8) [back to overview]	Duration of Objective Response Based on Investigator Assessment
NCT00679211 (8) [back to overview]	Duration of Objective Response as Assessed Through Independent Radiologic Review
NCT00679211 (8) [back to overview]	Progression-free Survival Based on Investigator Assessment
NCT00679341 (8) [back to overview]	Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00679341 (8) [back to overview]	Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00679341 (8) [back to overview]	Time to Symptom Progression
NCT00679341 (8) [back to overview]	Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)
NCT00679341 (8) [back to overview]	Overall Survival
NCT00679341 (8) [back to overview]	Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00679341 (8) [back to overview]	Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab
NCT00679341 (8) [back to overview]	Plasma Concentration of Free Emtansine
NCT00829166 (17) [back to overview]	Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)
NCT00829166 (17) [back to overview]	PFS as Assessed by the Investigator
NCT00829166 (17) [back to overview]	Percentage of Participants With Treatment Failure
NCT00829166 (17) [back to overview]	Percentage of Participants With Symptom Progression
NCT00829166 (17) [back to overview]	Percentage of Participants With PD or Death as Assessed by the Investigator
NCT00829166 (17) [back to overview]	Time to Treatment Failure
NCT00829166 (17) [back to overview]	Time to Symptom Progression
NCT00829166 (17) [back to overview]	Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
NCT00829166 (17) [back to overview]	Percentage of Participants With Objective Response (OR) as Assessed by an IRC
NCT00829166 (17) [back to overview]	Percentage of Participants With Clinical Benefit as Assessed by an IRC
NCT00829166 (17) [back to overview]	Percentage of Participants Who Were Alive at Year 2
NCT00829166 (17) [back to overview]	Percentage of Participants Who Died: Second Interim Analysis
NCT00829166 (17) [back to overview]	Percentage of Participants Who Died: Final Analysis
NCT00829166 (17) [back to overview]	Overall Survival: Second Interim Analysis (Co-primary Endpoint)
NCT00829166 (17) [back to overview]	Overall Survival: Final Analysis
NCT00829166 (17) [back to overview]	Duration of Objective Response (DOR) as Assessed by an IRC
NCT00829166 (17) [back to overview]	Percentage of Participants Who Were Alive at Year 1
NCT00875979 (3) [back to overview]	Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00875979 (3) [back to overview]	Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00875979 (3) [back to overview]	Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00934856 (30) [back to overview]	Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population
NCT00934856 (30) [back to overview]	Percentage of Participants With Pathological CR (pCR) - LABC Population
NCT00934856 (30) [back to overview]	Percentage of Participants With Progression-Free Survival (PFS) Event - MBC Population
NCT00934856 (30) [back to overview]	Volume of Distribution at Steady State (Vss) of Serum Trastuzumab Emtansine
NCT00934856 (30) [back to overview]	Percentage of Participants With Treatment Failure - MBC Population
NCT00934856 (30) [back to overview]	PFS - MBC Population
NCT00934856 (30) [back to overview]	Time to Treatment Failure (TTF) - MBC Population
NCT00934856 (30) [back to overview]	Apparent Terminal Half-Life (t1/2) of Serum Trastuzumab Emtansine
NCT00934856 (30) [back to overview]	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Serum Trastuzumab Emtansine
NCT00934856 (30) [back to overview]	AUCinf of Plasma DM1
NCT00934856 (30) [back to overview]	AUCinf of Plasma Docetaxel
NCT00934856 (30) [back to overview]	AUCinf of Total Serum Trastuzumab
NCT00934856 (30) [back to overview]	CL of Plasma Docetaxel
NCT00934856 (30) [back to overview]	CL of Total Serum Trastuzumab
NCT00934856 (30) [back to overview]	Clearance (CL) of Serum Trastuzumab Emtansine
NCT00934856 (30) [back to overview]	Cmax of Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1)
NCT00934856 (30) [back to overview]	Cmax of Total Serum Trastuzumab
NCT00934856 (30) [back to overview]	Maximum Observed Concentration (Cmax) of Serum Trastuzumab Emtansine
NCT00934856 (30) [back to overview]	Number of Participants With Anti-Therapeutic Antibody (ATA) Response to Trastuzumab - MBC and LABC Population
NCT00934856 (30) [back to overview]	Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) - MBC and LABC Population
NCT00934856 (30) [back to overview]	Cmax of Plasma Docetaxel
NCT00934856 (30) [back to overview]	t1/2 of Plasma DM1
NCT00934856 (30) [back to overview]	t1/2 of Plasma Docetaxel
NCT00934856 (30) [back to overview]	t1/2 of Total Serum Trastuzumab
NCT00934856 (30) [back to overview]	Duration of Response - MBC Population
NCT00934856 (30) [back to overview]	Vss of Plasma Docetaxel
NCT00934856 (30) [back to overview]	Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population
NCT00934856 (30) [back to overview]	Vss of Total Serum Trastuzumab
NCT00934856 (30) [back to overview]	Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) - MBC Population
NCT00934856 (30) [back to overview]	Percentage of Participants With a BOR of CR or PR - LABC Population
NCT00943670 (23) [back to overview]	Duration of Objective Response Based on Investigator Assessment During the Single-agent Trastuzumab Emtansine Treatment Period
NCT00943670 (23) [back to overview]	Clearance T-DM1 and Total Trastuzumab
NCT00943670 (23) [back to overview]	Maximum Observed Serum Concentration of T-DM1 and Total Trastuzumab
NCT00943670 (23) [back to overview]	Number of Participants With Adverse Events (AEs)
NCT00943670 (23) [back to overview]	Number of Participants With Anti-therapeutic Antibodies (ATAs) to Trastuzumab Emtansine
NCT00943670 (23) [back to overview]	Number of Participants With Decreased Ejection Fraction
NCT00943670 (23) [back to overview]	Percentage of Participants With New Abnormal T Waves
NCT00943670 (23) [back to overview]	Percentage of Participants With New Abnormal U Waves
NCT00943670 (23) [back to overview]	Percentage of Participants Within Each Absolute QTc Interval Category
NCT00943670 (23) [back to overview]	Percentage of Participants Within Each Baseline-adjusted QTc Interval Category
NCT00943670 (23) [back to overview]	Terminal Half-life for T-DM1 and Total Trastuzumab
NCT00943670 (23) [back to overview]	Volume of Distribution at Steady State for T-DM1 and Total Trastuzumab
NCT00943670 (23) [back to overview]	Percentage of Participants With an Objective Response During the Single-agent Trastuzumab Emtansine Treatment Period
NCT00943670 (23) [back to overview]	Percentage of Participants With Clinical Benefit During the Single-agent Trastuzumab Emtansine Treatment Period
NCT00943670 (23) [back to overview]	Progression-free Survival During the Single-agent Trastuzumab Emtansine Treatment Period
NCT00943670 (23) [back to overview]	Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity for T-DM1 and Total Trastuzumab
NCT00943670 (23) [back to overview]	Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration for T-DM1 and Total Trastuzumab
NCT00943670 (23) [back to overview]	Change From Baseline in Heart Rate
NCT00943670 (23) [back to overview]	Change From Baseline in Mean Duration of the QTc Interval
NCT00943670 (23) [back to overview]	Change From Baseline in Mean Duration of the QTc Interval Using Bazett's Correction
NCT00943670 (23) [back to overview]	Change From Baseline in PR Interval
NCT00943670 (23) [back to overview]	Change From Baseline in QRS Duration
NCT00943670 (23) [back to overview]	Change From Baseline in Uncorrected QT Interval
NCT00951665 (22) [back to overview]	Percentage of Participants With Clinical Benefit
NCT00951665 (22) [back to overview]	Duration of Objective Response
NCT00951665 (22) [back to overview]	Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After Q3W Dose Regimen
NCT00951665 (22) [back to overview]	Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After QW Dose Regimen
NCT00951665 (22) [back to overview]	Maximum Tolerated Dose of Paclitaxel When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab
NCT00951665 (22) [back to overview]	Maximum Tolerated Dose of T-DM1 When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab
NCT00951665 (22) [back to overview]	Number of Participants in Phase IIa of the Study Who Received 12 or More Paclitaxel Doses in Combination With T-DM1 and/or Pertuzumab
NCT00951665 (22) [back to overview]	Number of Participants With Dose Limiting Toxicity (DLT) of the Combination of T-DM1 and Paclitaxel When T-DM1 Was Administered on Either an Q3W or QW Schedule for Both With and Without Pertuzumab Treatment
NCT00951665 (22) [back to overview]	Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)
NCT00951665 (22) [back to overview]	Percentage of Participants With Objective Response Rate (ORR)
NCT00951665 (22) [back to overview]	Progression-free Survival (PFS)
NCT00951665 (22) [back to overview]	An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
NCT00951665 (22) [back to overview]	An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
NCT00951665 (22) [back to overview]	Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
NCT00951665 (22) [back to overview]	Area Under the Serum Concentration-time Curve of Total Exposure (AUC0-Day 21) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen
NCT00951665 (22) [back to overview]	Area Under the Serum Concentration-time Curve of Total Exposure (AUClast) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen
NCT00951665 (22) [back to overview]	Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
NCT00951665 (22) [back to overview]	Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen
NCT00951665 (22) [back to overview]	Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen
NCT00951665 (22) [back to overview]	Number of Participants Who Had Adverse Events That Required Dose Modification of T-DM1 or Paclitaxel
NCT00951665 (22) [back to overview]	Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
NCT00951665 (22) [back to overview]	Number of Participants With Change From Baseline in Cardiac Function
NCT01120184 (38) [back to overview]	Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score
NCT01120184 (38) [back to overview]	Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels
NCT01120184 (38) [back to overview]	Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels
NCT01120184 (38) [back to overview]	Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels
NCT01120184 (38) [back to overview]	Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
NCT01120184 (38) [back to overview]	Percentage of Participants Who Died Prior to Clinical Cutoff
NCT01120184 (38) [back to overview]	Percentage of Participants Who Died at 2 Years
NCT01120184 (38) [back to overview]	Percentage of Participants Experiencing Treatment Failure
NCT01120184 (38) [back to overview]	Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score
NCT01120184 (38) [back to overview]	Overall Survival Truncated at 2 Years
NCT01120184 (38) [back to overview]	Overall Survival (OS) at Clinical Cutoff
NCT01120184 (38) [back to overview]	OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels
NCT01120184 (38) [back to overview]	OS at Clinical Cutoff Among Those With High HER2 mRNA Levels
NCT01120184 (38) [back to overview]	One-Year Survival Rate
NCT01120184 (38) [back to overview]	Hospitalization Days
NCT01120184 (38) [back to overview]	Duration of Response According to IRF Assessment
NCT01120184 (38) [back to overview]	Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score
NCT01120184 (38) [back to overview]	Time to Treatment Failure (TTF)
NCT01120184 (38) [back to overview]	PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels
NCT01120184 (38) [back to overview]	PFS According to IRF Assessment Among Those With High HER2 mRNA Levels
NCT01120184 (38) [back to overview]	PFS According to Investigator Assessment
NCT01120184 (38) [back to overview]	Percentage of Participants With Objective Response According to IRF Assessment
NCT01120184 (38) [back to overview]	Percentage of Participants With Objective Response According to Investigator Assessment
NCT01120184 (38) [back to overview]	Percentage of Participants With Hospitalization
NCT01120184 (38) [back to overview]	Percentage of Participants With Grade 5 Adverse Events
NCT01120184 (38) [back to overview]	Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
NCT01120184 (38) [back to overview]	Percentage of Participants With Grade ≥3 Adverse Events
NCT01120184 (38) [back to overview]	Progression-Free Survival (PFS) According to IRF Assessment
NCT01120184 (38) [back to overview]	Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels
NCT01120184 (38) [back to overview]	Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels
NCT01120184 (38) [back to overview]	Percentage of Participants With Death or Disease Progression According to Investigator Assessment
NCT01120184 (38) [back to overview]	Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels
NCT01120184 (38) [back to overview]	Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
NCT01120184 (38) [back to overview]	Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score
NCT01120184 (38) [back to overview]	Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
NCT01120184 (38) [back to overview]	Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
NCT01120184 (38) [back to overview]	Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module
NCT01120184 (38) [back to overview]	Percentage of Participants With Grade 3-4 Laboratory Parameters
NCT01196052 (7) [back to overview]	Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment
NCT01196052 (7) [back to overview]	Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment
NCT01196052 (7) [back to overview]	Percentage of Participants With a Pathological Complete Response
NCT01196052 (7) [back to overview]	Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay
NCT01196052 (7) [back to overview]	Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment
NCT01196052 (7) [back to overview]	Adverse Events, LVEF Function, and Deaths
NCT01196052 (7) [back to overview]	Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment
NCT01419197 (9) [back to overview]	6-month and 1-year Survival
NCT01419197 (9) [back to overview]	Time to Pain Symptom Progression
NCT01419197 (9) [back to overview]	Progression-free Survival
NCT01419197 (9) [back to overview]	Percentage of Participants With an Objective Response
NCT01419197 (9) [back to overview]	Overall Survival (Final Analysis)
NCT01419197 (9) [back to overview]	Overall Survival
NCT01419197 (9) [back to overview]	Duration of the Objective Response
NCT01419197 (9) [back to overview]	Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle
NCT01419197 (9) [back to overview]	6-month and 1-year Survival (Final Analysis)
NCT01609556 (24) [back to overview]	Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D
NCT01609556 (24) [back to overview]	Clearance (CL) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
NCT01609556 (24) [back to overview]	CL of DM4 and S-Methyl DM4 at RP2D
NCT01609556 (24) [back to overview]	AUClast of Free DM4 and S-Methyl DM4 at RP2D
NCT01609556 (24) [back to overview]	AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D
NCT01609556 (24) [back to overview]	Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
NCT01609556 (24) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
NCT01609556 (24) [back to overview]	Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
NCT01609556 (24) [back to overview]	Number of Participants With TEAEs
NCT01609556 (24) [back to overview]	Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study
NCT01609556 (24) [back to overview]	Cmax of Free DM4 and S-Methyl DM4 at RP2D
NCT01609556 (24) [back to overview]	Time to Progression (TTP) as Assessed by RECIST v1.1
NCT01609556 (24) [back to overview]	Duration of Response (DOR) as Assessed by RECIST v1.1
NCT01609556 (24) [back to overview]	Progression-Free Survival (PFS) as Assessed by RECIST v1.1
NCT01609556 (24) [back to overview]	Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
NCT01609556 (24) [back to overview]	Number of Participants With Treatment-Emergent Ocular AEs
NCT01609556 (24) [back to overview]	Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses
NCT01609556 (24) [back to overview]	Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs
NCT01609556 (24) [back to overview]	Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
NCT01609556 (24) [back to overview]	Number of Participants With Anti-Drug Antibodies (ADA)
NCT01609556 (24) [back to overview]	Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine
NCT01609556 (24) [back to overview]	Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine
NCT01609556 (24) [back to overview]	Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
NCT01609556 (24) [back to overview]	Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
NCT01641939 (17) [back to overview]	Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3
NCT01641939 (17) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2
NCT01641939 (17) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1
NCT01641939 (17) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1
NCT01641939 (17) [back to overview]	Duration of Objective Response (DOR) - Phase 3
NCT01641939 (17) [back to overview]	Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)
NCT01641939 (17) [back to overview]	Overall Survival (OS)- Phase 3
NCT01641939 (17) [back to overview]	Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3
NCT01641939 (17) [back to overview]	Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3
NCT01641939 (17) [back to overview]	Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3
NCT01641939 (17) [back to overview]	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1
NCT01641939 (17) [back to overview]	Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3
NCT01641939 (17) [back to overview]	Volume of Distribution at Steady State (Vss) - Stage 1
NCT01641939 (17) [back to overview]	Systemic Clearance (CL) - Stage 1
NCT01641939 (17) [back to overview]	Plasma Decay Half-Life (t1/2) - Stage 1
NCT01641939 (17) [back to overview]	Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3
NCT01641939 (17) [back to overview]	Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): t1/2 of Capecitabine
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) of Capecitabine
NCT01702558 (34) [back to overview]	Phase 1 (mBC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Maximum Observed Plasma Concentration (Cmax) of Capecitabine
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks)
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs)
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Plasma Terminal Half-Life (t1/2) of Capecitabine
NCT01702558 (34) [back to overview]	Phase 1 (mBC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Duration of Response (DoR) as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Overall Survival (OS)
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Percentage of Participants Who Died of Any Cause
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Percentage of Participants With Clinical Benefit as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1 or Death From Any Cause
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Percentage of Participants With Treatment Failure as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Progression-Free Survival (PFS) as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Time to Progression (TTP) as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Time to Response (TTR) as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): Serum Concentration of Trastuzumab
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): Serum Concentration of Trastuzumab Emtansine
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Serum Concentration of Trastuzumab
NCT01702558 (34) [back to overview]	Phase 1 (mBC): Serum Concentration of Trastuzumab Emtansine
NCT01702558 (34) [back to overview]	Phase 2 (mBC): Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): AUC(0-inf) of Capecitabine
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): Cmax of Capecitabine
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW)
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1
NCT01702558 (34) [back to overview]	Phase 1 (LA/mGC): Percentage of Participants With DLTs
NCT01702571 (11) [back to overview]	Duration of Response (DOR) According to RECIST v 1.1
NCT01702571 (11) [back to overview]	Number of Hospital Visits
NCT01702571 (11) [back to overview]	Overall Survival
NCT01702571 (11) [back to overview]	Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
NCT01702571 (11) [back to overview]	Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
NCT01702571 (11) [back to overview]	Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
NCT01702571 (11) [back to overview]	Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
NCT01702571 (11) [back to overview]	Time to Response According to RECIST v 1.1
NCT01702571 (11) [back to overview]	Percentage of Participants With Specific AEPIs
NCT01702571 (11) [back to overview]	Type of Hospital Visits
NCT01702571 (11) [back to overview]	Percentage of Participants With Adverse Events of Special Interest (AESIs)
NCT01772472 (4) [back to overview]	Percentage of Participants With Adverse Events
NCT01772472 (4) [back to overview]	Invasive Disease-free Survival (IDFS)
NCT01772472 (4) [back to overview]	Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
NCT01772472 (4) [back to overview]	Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
NCT01853748 (21) [back to overview]	Percentage of Activity Impairment Because of Health
NCT01853748 (21) [back to overview]	Quality of Life (QOL) FACT B Total Score at Week 12
NCT01853748 (21) [back to overview]	Quality of Life (QOL) FACT B Total Score at Baseline
NCT01853748 (21) [back to overview]	Quality of Life (QOL) FACT B Total Score at 24 Months
NCT01853748 (21) [back to overview]	Quality of Life (QOL) FACT B Total Score at 18 Months
NCT01853748 (21) [back to overview]	Quality of Life (QOL) FACT B Total Score at 6 Months
NCT01853748 (21) [back to overview]	Number of Incidence of T-DM1 Induced Grade 2-3 Thrombocytopenia
NCT01853748 (21) [back to overview]	Number of Patients Have Alopecia
NCT01853748 (21) [back to overview]	Number of SNPs With Top Associations of Trastuzumab Emtansine-induced Grade 2-4 Thrombocytopenia in the T-DM1 Arm
NCT01853748 (21) [back to overview]	Quality of Life (QOL) FACT B Total Score at 1 Year
NCT01853748 (21) [back to overview]	Number of Participants of Clinically Relevant Toxicities (CRT)
NCT01853748 (21) [back to overview]	Percentage of Impairment While Working Because of Health (Mean, SD)
NCT01853748 (21) [back to overview]	Quality of Life (QOL) FACT B Total Score at Week 3
NCT01853748 (21) [back to overview]	Percentage of Work Time Missed Because of Health
NCT01853748 (21) [back to overview]	Percentage of Patients With Amenorrhea
NCT01853748 (21) [back to overview]	3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)
NCT01853748 (21) [back to overview]	Percentage of Overall Work Impairment Because of Health
NCT01853748 (21) [back to overview]	3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status
NCT01853748 (21) [back to overview]	Incidence Rate of Grade 3-4 Treatment-Related Toxicity
NCT01853748 (21) [back to overview]	Median Overall Survival (OS)
NCT01853748 (21) [back to overview]	Number of Incidence of Grade 3-4 Cardiac Left Ventricular Dysfunction
NCT01904903 (4) [back to overview]	Absolute Changes in LVEF During HER2 Targeted Therapy Between Baseline and End of Treatment
NCT01904903 (4) [back to overview]	HER2 Therapy Holds Attributed to Proportion of Patients With Symptomatic or Asymptomatic Cardiotoxicity.
NCT01904903 (4) [back to overview]	Median Time to Development of an Event Defined as Cardiac Event or Asymptomatic Worsening of Left Ventricular Dysfunction, Among Patients Who Developed One Event.
NCT01904903 (4) [back to overview]	Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function.
NCT01966471 (12) [back to overview]	IDFS Plus Second Primary Non-Breast Cancer
NCT01966471 (12) [back to overview]	Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
NCT01966471 (12) [back to overview]	Invasive Disease-Free Survival (IDFS) in the Overall Population
NCT01966471 (12) [back to overview]	Percentage of Participants With Adverse Events
NCT01966471 (12) [back to overview]	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
NCT01966471 (12) [back to overview]	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
NCT01966471 (12) [back to overview]	Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
NCT01966471 (12) [back to overview]	Overall Survival (OS)
NCT01966471 (12) [back to overview]	Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment
NCT01966471 (12) [back to overview]	Disease-Free Survival (DFS)
NCT01966471 (12) [back to overview]	Distant Recurrence-Free Interval (DRFI)
NCT01966471 (12) [back to overview]	EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
NCT02038010 (8) [back to overview]	Clinical Benefit Rate (CBR) of BYL719 Administered in Combination With T-DM1 by Cohort
NCT02038010 (8) [back to overview]	Maximum Tolerated Dose (MTD) of BYL719 in Combination With T-DM1.
NCT02038010 (8) [back to overview]	Objective Response Rate (ORR) of BYL719 Administered in Combination With T-DM1 by Cohort
NCT02038010 (8) [back to overview]	Best Response of BYL719 Administered in Combination With T-DM1 by Cohort
NCT02038010 (8) [back to overview]	Dose Limiting Toxicity (DLT) of Dose-escalating BYL719 in Combination With T-DM1
NCT02038010 (8) [back to overview]	Number of Patients With Changes in PIK3CA Gene, PTEN Expression and Akt/mTOR Downstream Markers
NCT02038010 (8) [back to overview]	Progression-Free Survival (PFS) of BYL719 Administered in Combination With T-DM1 for All Patients Treated on Study.
NCT02038010 (8) [back to overview]	Toxicity of the Combination of BYL719 and T-DM1 Treatment by Cohort
NCT02131064 (22) [back to overview]	Cmin of Trastuzumab Emtansine and Total Trastuzumab
NCT02131064 (22) [back to overview]	Maximum Observed Serum Concentration (Cmax) of Trastuzumab
NCT02131064 (22) [back to overview]	Minimum Observed Serum Concentration (Cmin) of Trastuzumab
NCT02131064 (22) [back to overview]	Percentage of Participants by Response for Hair Loss Single Item
NCT02131064 (22) [back to overview]	Percentage of Participants by Response for Neuropathy Single Item
NCT02131064 (22) [back to overview]	Percentage of Participants by Response for Skin Problem Single Items
NCT02131064 (22) [back to overview]	Percentage of Participants With a Clinically Meaningful Deterioration in Function Subscales
NCT02131064 (22) [back to overview]	Percentage of Participants With a Clinically Meaningful Increase in Symptom Subscales
NCT02131064 (22) [back to overview]	Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TDM-1
NCT02131064 (22) [back to overview]	Percentage of Participants With ATA to Trastuzumab
NCT02131064 (22) [back to overview]	Percentage of Participants With Selected Adverse Events (AEs)
NCT02131064 (22) [back to overview]	Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) Concentrations
NCT02131064 (22) [back to overview]	Serum Levels of Plasma DM1-Containing Catabolites Concentrations (in ng/mL) (Nonreducible Thioether Linker [MCC]-DM1 and Lysine [Lys]-MCC-DM1)
NCT02131064 (22) [back to overview]	Time to Clinically Meaningful Deterioration in Function Subscale
NCT02131064 (22) [back to overview]	Invasive Disease-free Survival (IDFS)
NCT02131064 (22) [back to overview]	Event-Free Survival
NCT02131064 (22) [back to overview]	Overall Survival
NCT02131064 (22) [back to overview]	Percentage of Participants Who Received Breast-Conserving Surgery (BCS)
NCT02131064 (22) [back to overview]	Percentage of Participants With a Clinically Meaningful Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Score
NCT02131064 (22) [back to overview]	Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples
NCT02131064 (22) [back to overview]	Time to Clinically Meaningful Deterioration in GHS/QoL Score
NCT02131064 (22) [back to overview]	Cmax of Trastuzumab Emtansine and Total Trastuzumab
NCT02144012 (14) [back to overview]	Immunogenicity: Percentage of Positive Anti-Therapeutic Antibody (ATA) Response to Trastuzumab Emtansine
NCT02144012 (14) [back to overview]	One-Year Survival Rate
NCT02144012 (14) [back to overview]	Objective Response Rate (ORR)
NCT02144012 (14) [back to overview]	Duration of Response (DOR)
NCT02144012 (14) [back to overview]	Patient-Reported Outcomes: Number of Participants Who Completed the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire
NCT02144012 (14) [back to overview]	Overall Survival (OS)
NCT02144012 (14) [back to overview]	Patient-Reported Outcomes: Number of Participants Who Completed the FACT-Taxane Questionnaire
NCT02144012 (14) [back to overview]	Safety: Percentage of Participants With Significant Decline in Left Ventricular Ejection Fraction (LVEF)
NCT02144012 (14) [back to overview]	Safety: Percentage of Participants With Grade 3 and 4 AEs
NCT02144012 (14) [back to overview]	Safety: Percentage of Participants With Adverse Events Leading to Treatment Interruption
NCT02144012 (14) [back to overview]	Safety: Percentage of Participants With Adverse Events Leading to Dose Reduction
NCT02144012 (14) [back to overview]	Safety: Percentage of Participants With Adverse Events (AEs)
NCT02144012 (14) [back to overview]	Progression-Free Survival (PFS)
NCT02144012 (14) [back to overview]	Percentage of Participants With Adverse Events Leading to Treatment Discontinuation
NCT02226276 (2) [back to overview]	Relationship Between Tumor Minimum Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response
NCT02226276 (2) [back to overview]	Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response
NCT02289833 (16) [back to overview]	Percentage of Participants With DOR Event of Disease Progression, Assessed According to RECIST v1.1
NCT02289833 (16) [back to overview]	Volume of Distribution (Vss) for Trastuzumab Emtansine and Total Trastuzumab
NCT02289833 (16) [back to overview]	Percentage of Participants With Clinical Benefit as Per Investigator Assessment According to RECIST, v1.1
NCT02289833 (16) [back to overview]	Maximum Observed Concentration (Cmax) for N2'- Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1)
NCT02289833 (16) [back to overview]	Duration of Objective Response (DOR) Assessed According to RECIST v1.1
NCT02289833 (16) [back to overview]	Overall Survival (OS)
NCT02289833 (16) [back to overview]	Elimination Half-Life (t1/2) for Trastuzumab Emtansine and Total Trastuzumab
NCT02289833 (16) [back to overview]	Clearance (CL) for Trastuzumab Emtansine and Total Trastuzumab
NCT02289833 (16) [back to overview]	AUCinf for Trastuzumab Emtansine and Total Trastuzumab
NCT02289833 (16) [back to overview]	Progression-Free Survival (PFS) as Per Investigator Assessment According to RECIST v. 1.1
NCT02289833 (16) [back to overview]	Percentage of Participants Who Died
NCT02289833 (16) [back to overview]	Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)
NCT02289833 (16) [back to overview]	Percentage of Participants With PFS Event of Disease Progression, as Per Investigator Assessment According to RECIST v. 1.1, or Death
NCT02289833 (16) [back to overview]	Percentage of Participants With Objective Response as Per Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v. 1.1)
NCT02289833 (16) [back to overview]	Maximum Observed Concentration (Cmax) for Trastuzumab Emtansine and Total Trastuzumab
NCT02289833 (16) [back to overview]	Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
NCT02420873 (1) [back to overview]	Overall Response Rate (ORR) of IMGN901 in Participants CD56 Expressing Hematological Malignancies
NCT02452554 (2) [back to overview]	Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1
NCT02452554 (2) [back to overview]	Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0
NCT02610140 (13) [back to overview]	Progression-free Survival (PFS), [95% CI]
NCT02610140 (13) [back to overview]	Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma
NCT02610140 (13) [back to overview]	Percentage of Participants With Confirmed Improvement of Pain
NCT02610140 (13) [back to overview]	Overall Survival (OS), [95% CI]
NCT02610140 (13) [back to overview]	Overall Survival (OS) - Addendum
NCT02610140 (13) [back to overview]	Objective Response Rate (ORR)
NCT02610140 (13) [back to overview]	Number of Deaths
NCT02610140 (13) [back to overview]	Duration of Response (DOR)
NCT02610140 (13) [back to overview]	Durable Response Rate (DRR)
NCT02610140 (13) [back to overview]	Disease Control Rate (DCR)
NCT02610140 (13) [back to overview]	Time to Worsening of Pain
NCT02610140 (13) [back to overview]	Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)
NCT02610140 (13) [back to overview]	Time to Worsening of Symptoms Characteristic of Mesothelioma
NCT02631876 (11) [back to overview]	PFS, as Assessed by Investigator Per RECIST Version 1.1
NCT02631876 (11) [back to overview]	Overall Survival (OS)
NCT02631876 (11) [back to overview]	Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1
NCT02631876 (11) [back to overview]	Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses
NCT02631876 (11) [back to overview]	Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment
NCT02631876 (11) [back to overview]	Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4
NCT02631876 (11) [back to overview]	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02631876 (11) [back to overview]	Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1
NCT02631876 (11) [back to overview]	Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study
NCT02631876 (11) [back to overview]	Number of Participants With Anti-Drug Antibodies (ADA)
NCT02631876 (11) [back to overview]	PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)
NCT02658084 (1) [back to overview]	Phase 1 - Rate of Participants Experiencing Adverse Events
NCT02658734 (16) [back to overview]	Percentage of Participants With Adverse Events
NCT02658734 (16) [back to overview]	Overall Survival (OS)
NCT02658734 (16) [back to overview]	Overall Response Rate (ORR)
NCT02658734 (16) [back to overview]	Exposure to Study Drug
NCT02658734 (16) [back to overview]	Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication
NCT02658734 (16) [back to overview]	Percentage of Participants With Adverse Events Leading to Interruption of Study Medication
NCT02658734 (16) [back to overview]	Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram
NCT02658734 (16) [back to overview]	Percentage of Participants With Serious Adverse Events (SAEs)
NCT02658734 (16) [back to overview]	Progression-Free Survival (PFS)
NCT02658734 (16) [back to overview]	Percentage of Participants With Non-Serious Adverse Events of Special Interest
NCT02658734 (16) [back to overview]	Laboratory Results Abnormalities
NCT02658734 (16) [back to overview]	Percentage of Participants With Adverse Events Leading to Modification of Study Medication
NCT02658734 (16) [back to overview]	Severity of Adverse Events
NCT02658734 (16) [back to overview]	Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
NCT02658734 (16) [back to overview]	Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria
NCT02658734 (16) [back to overview]	Percentage of Participants With Congestive Heart Failure
NCT02839681 (4) [back to overview]	Proportion of Subjects Who Experienced a Partial or Complete Response
NCT02839681 (4) [back to overview]	Progression Free Survival
NCT02839681 (4) [back to overview]	Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
NCT02839681 (4) [back to overview]	Overall Survival
NCT02924883 (11) [back to overview]	Percentage of Participants With Adverse Events
NCT02924883 (11) [back to overview]	Percentage of Participants With ATAs to Trastuzumab Emtansine
NCT02924883 (11) [back to overview]	Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to Atezolizumab
NCT02924883 (11) [back to overview]	Duration of OR as Determined by Investigator's Tumor Assessment Using RECIST v1.1
NCT02924883 (11) [back to overview]	Cmax of Total Trastuzumab
NCT02924883 (11) [back to overview]	Cmax of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1)
NCT02924883 (11) [back to overview]	Cmax of Atezolizumab
NCT02924883 (11) [back to overview]	Percentage of Participants With Objective Response (OR) as Determined by Investigator's Tumor Assessment Using RECIST v1.1
NCT02924883 (11) [back to overview]	Progression-Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
NCT02924883 (11) [back to overview]	Overall Survival (OS)
NCT02924883 (11) [back to overview]	Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine
NCT02999672 (6) [back to overview]	Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria
NCT02999672 (6) [back to overview]	Overall Survival (OS)
NCT02999672 (6) [back to overview]	Plasma/Serum Concentrations of Trastuzumab Emtansine
NCT02999672 (6) [back to overview]	Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
NCT02999672 (6) [back to overview]	Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
NCT02999672 (6) [back to overview]	Progression-Free Survival (PFS)
NCT03023722 (2) [back to overview]	Time to Progression
NCT03023722 (2) [back to overview]	Drug Toxicity
NCT03106077 (5) [back to overview]	Number of Metastatic Participants With Radiographic Response
NCT03106077 (5) [back to overview]	Number of Participants With Progressive Disease
NCT03106077 (5) [back to overview]	Number of Participants With Radiographic Response Rate
NCT03106077 (5) [back to overview]	Number of Participants With Stable Disease
NCT03106077 (5) [back to overview]	Number of Metastatic Participants With Duration of Response
NCT03364348 (8) [back to overview]	Objective Tumor Response (ORR)
NCT03364348 (8) [back to overview]	Adverse Events by Severity Grade 1 to 5
NCT03364348 (8) [back to overview]	Adverse Event Relationship to Study Drugs
NCT03364348 (8) [back to overview]	Time-to-tumor Response (TTR)
NCT03364348 (8) [back to overview]	Laboratory Value Abnormalities
NCT03364348 (8) [back to overview]	Duration of Response (DoR)
NCT03364348 (8) [back to overview]	Dose-limiting Toxicities (DLTs)
NCT03364348 (8) [back to overview]	Progression-free Survival (PFS)
NCT03529110 (5) [back to overview]	Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
NCT03529110 (5) [back to overview]	Percentage of Participants With Objective Response Rate (ORR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
NCT03529110 (5) [back to overview]	Duration of Response (DoR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
NCT03529110 (5) [back to overview]	Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
NCT03529110 (5) [back to overview]	Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
NCT03726879 (16) [back to overview]	pCR in the ITT Population
NCT03726879 (16) [back to overview]	Percentage of Participants With Adverse Events
NCT03726879 (16) [back to overview]	Mean Changes From Baseline in Global Health Status
NCT03726879 (16) [back to overview]	Percentage of Participants With Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3)
NCT03726879 (16) [back to overview]	Percentage of Participants With pCR in the PD-L1-Negative Population
NCT03726879 (16) [back to overview]	Mean Changes From Baseline in Function (Role, Physical)
NCT03726879 (16) [back to overview]	Mean Changes From Baseline in Function (Role, Physical)
NCT03726879 (16) [back to overview]	Maximum Serum Concentration (Cmax) of Atezolizumab
NCT03726879 (16) [back to overview]	Minimum Serum Concentration (Cmin) of Atezolizumab
NCT03726879 (16) [back to overview]	Number of Participants With Treatment-Emergent ADAs to Pertuzumab
NCT03726879 (16) [back to overview]	Number of Participants With Treatment-Emergent ADAs to Trastuzumab
NCT03726879 (16) [back to overview]	Mean Changes From Baseline in Global Health Status
NCT03726879 (16) [back to overview]	Percentage of Participants With pCR Based on Hormone Receptor Status
NCT03726879 (16) [back to overview]	Percentage of Participants With pCR Based on PIK3CA Mutation Status
NCT03726879 (16) [back to overview]	Trough Concentration (Ctrough) for Pertuzumab and Trastuzumab in Serum
NCT03726879 (16) [back to overview]	Number of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) to Atezolizumab
NCT03926143 (2) [back to overview]	Overall Survival
NCT03926143 (2) [back to overview]	Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
NCT04296942 (4) [back to overview]	Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC)
NCT04296942 (4) [back to overview]	Progression-free Survival (PFS) in Triple Negative Breast Cancer (TNBC)
NCT04296942 (4) [back to overview]	Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
NCT04296942 (4) [back to overview]	Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents
NCT04439110 (3) [back to overview]	Progression Free Survival (PFS)
NCT04439110 (3) [back to overview]	Objective Response Rate (ORR)
NCT04439110 (3) [back to overview]	6 Months Progression-free Survival (PFS) Rate

Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)

For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response. (NCT00509769)
Timeframe: Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)

Intervention	Months (Median)
Trastuzumab Emtansine 3.6 mg/kg	NA

Intervention	Percentage of patients (Number)
	Month 6 (n=109)	Month 12 (n=108)
Trastuzumab Emtansine 3.6 mg/kg	25.7	26.9

Intervention	day•μg/mL (Mean)
	Trastuzumab emtansine Cycle 1 (n=62)	Trastuzumab emtansine Cycle 5 (n=39)	Total trastuzumab Cycle 1 (n=60)	Total trastuzumab Cycle 5 (n=38)
Trastuzumab Emtansine 3.6 mg/kg	495	473	700	788

Intervention	ng/mL (Mean)
	Cycle 1 (n=62)	Cycle 5 (n=39)
Trastuzumab Emtansine 3.6 mg/kg	5.11	4.71

Intervention	Percentage of patients (Number)
Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg	66.7
Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg	40.6

Intervention	Months (Median)
Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg	8.6
Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg	13.9

Intervention	Months (Median)
Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg	13.8
Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg	6.6

Intervention	percentage of participants (Number)
LABC: T-DM1 + Doc (Doublet Regimen)	60.0
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)	60.6

Intervention	mL/kg (Mean)
	Cycle 1	Cycle 2
LABC: T-DM1 3.6 mg/kg	33.2	28.8
MBC: T-DM1 2.4 mg/kg	22.1	17.7
MBC: T-DM1 3.6 mg/kg	33.2	31.4

Intervention	hr*ng/mL (Mean)
	Cycle 1	Cycle 2
LABC: Docetaxel 100 mg/m^2	4020	3840
LABC: Docetaxel 60 mg/m^2	1540	3260
LABC: Docetaxel 75 mg/m^2	2140	2420
MBC: Docetaxel 60 mg/m^2	1560	1710
MBC: Docetaxel 75 mg/m^2	1050	1700

Intervention	percentage of participants (Number)
	AEs	SAEs
LABC: T-DM1 + Doc (Doublet Regimen)	100	22.5
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)	100	27.3
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)	100	33.3
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)	100	66.7
MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)	100	33.3
MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)	100	40.0

Intervention	percentage of participants (Number)
LABC: T-DM1 + Doc (Doublet Regimen)	70.0
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)	51.5

Intervention	mL/day/kg (Mean)
	Cycle 1: T-DM1 [N=51]	Cycle 1: Total trastuzumab [N=51]	Cycle 3: T-Dm1 [N=47]	Cycle 3: Total trastuzumab [N=47]
Single-Agent T-DM1 Treatment	9.17	4.21	7.91	3.12

Intervention	participants (Number)
	Any adverse event	Grade ≥ 3 adverse events	Serious adverse events	Adverse events leading to treatment discontinuatio	Deaths
T-DM1	51	17	4	2	0
T-DM1 + Pertuzumab	18	12	5	5	0

Intervention	percentage of participants (Number)
	Significant: C1D1, 15 minutes post-dose [N=44]	Significant: C1D1, 60 minutes post-dose [N=45]	Significant: C1D8 [N=43]	Significant: C3D1, 15 minutes pre-dose [N=35]	Significant: C3D1, 15 minutes post-dose [N=36]	Significant: C3D1, 60 minutes post-dose [N=37]	Non-Significant: C1D1, 15 minutes post-dose [N=44]	Non-Significant: C1D1, 60 minutes post-dose [N=45]	Non-Significant: C1D8 [N=43]	Non-Significant: C3D1, 15 minutes pre-dose [N=35]	Non-Significant: C3D1, 15 minutes post-dose [N=36]	Non-Significant: C3D1, 60 minutes post-dose [N=37]
T-DM1	0	0	2.3	0	0	0	13.6	11.1	20.9	17.1	13.9	27.0

Intervention	percentage of participants (Number)
	Cycle 1, Day 1, 15 minutes post-dose [N=44]	Cycle 1, Day 1, 60 minutes post-dose [N=45]	Cycle 1, Day 8 [N=43]	Cycle 3, Day 1, 15 minutes pre-dose [N=35]	Cycle 3, Day 1, 15 minutes post-dose [N=36]	Cycle 3, Day 1, 60 minutes post-dose [N=37]
T-DM1	0	0	0	0	0	0

Intervention	percentage of participants (Number)
	QTcF: Cycle 1, Day 1, 15 minutes post-dose [N=44]	QTcF: Cycle 1, Day 1, 60 minutes post-dose [N=45]	QTcF: Cycle 1, Day 8 [N=43]	QTcF: Cycle 3, Day 1, 15 minutes pre-dose [N=35]	QTcF: Cycle 3, Day 1, 15 minutes post-dose [N=37]	QTcF: Cycle 3, Day 1, 60 minutes post-dose [N=37]	QTcB: Cycle 1, Day 1, 15 minutes post-dose [N=44]	QTcB: Cycle 1, Day 1, 60 minutes post-dose [N=45]	QTcB: Cycle 1, Day 8 [N=43]	QTcB: Cycle 3, Day 1, 15 minutes pre-dose [N=35]	QTcB: Cycle 3, Day 1, 15 minutes post-dose [N=37]	QTcB: Cycle 3, Day 1, 60 minutes post-dose [N=37]
Average QTc Interval > 450 to ≤ 480 ms	0	0	0	2.9	5.4	2.7	20.5	26.7	20.9	17.1	29.7	29.7
Average QTc Interval > 480 to ≤ 500 ms	0	0	0	0	0	0	0	0	0	0	0	0
Average QTc Interval > 500 ms	0	0	0	0	0	0	0	0	0	0	0	0
Average QTc Interval ≤ 450 ms	100	100	100	97.1	94.6	97.3	79.5	73.3	79.1	82.9	70.3	70.3

Intervention	beats per minute (Mean)
	Cycle 1 Day 1, 15 minutes post-dose [N=44]	Cycle 1 Day 1, 60 minutes post-dose [N=45]	Cycle 1 Day 8 [N=43]	Cycle 3 Day 1, 15 minutes pre-dose [N=35]	Cycle 3 Day 1, 15 minutes post-dose [N=37]	Cycle 3 Day 1, 60 minutes post-dose [N=37]
T-DM1	2.9	4.4	5.4	4.1	0.8	2.4

Intervention	percentage of participants (Number)
Phase Ib Regimen 1	65.4
Phase Ib Regimen 2	80.0
Phase Ib Regimen 3	61.9
Phase Ib Regimen 4	66.7
Phase IIa Group A	54.5
Phase IIa Group B	59.1

Intervention	nano gram per milliliter (ng/mL) (Mean)
Phase Ib Cohort B	2.4
Phase Ib Cohort 1	3.4
Phase Ib Cohort J	2.7
Phase Ib Cohort D	3.2
Phase Ib Cohort 3B	5.1

Intervention	ng/mL (Mean)
Phase Ib Cohort 6	1.0
Phase Ib Cohort 7	1.8
Phase Ib Cohort 8	3.0
Phase Ib Cohort F	2.7
Phase Ib Cohort 4	4.0

maytansine

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Overview

Effects

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Research Demand Index: 41.92

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Clinical Trials (130)

Trial Overview

Trial Outcomes

Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)

Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)

Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)

Progression-free Survival as Assessed Through Independent Radiologic Review

Percentage of Participants With Clinical Benefit Based on Investigator Assessment

Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review

Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review

Objective Response Based on Investigator Assessment

Duration of Objective Response Based on Investigator Assessment

Duration of Objective Response as Assessed Through Independent Radiologic Review

Progression-free Survival Based on Investigator Assessment

Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Time to Symptom Progression

Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)

Overall Survival

Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab

Plasma Concentration of Free Emtansine

Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)

PFS as Assessed by the Investigator

Percentage of Participants With Treatment Failure

Percentage of Participants With Symptom Progression

Percentage of Participants With PD or Death as Assessed by the Investigator

Time to Treatment Failure

Time to Symptom Progression

Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)

Percentage of Participants With Objective Response (OR) as Assessed by an IRC

Percentage of Participants With Clinical Benefit as Assessed by an IRC

Percentage of Participants Who Were Alive at Year 2

Percentage of Participants Who Died: Second Interim Analysis

Percentage of Participants Who Died: Final Analysis

Overall Survival: Second Interim Analysis (Co-primary Endpoint)

Overall Survival: Final Analysis

Duration of Objective Response (DOR) as Assessed by an IRC

Percentage of Participants Who Were Alive at Year 1

Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population

Percentage of Participants With Pathological CR (pCR) - LABC Population

Percentage of Participants With Progression-Free Survival (PFS) Event - MBC Population

Volume of Distribution at Steady State (Vss) of Serum Trastuzumab Emtansine

Percentage of Participants With Treatment Failure - MBC Population

PFS - MBC Population

Time to Treatment Failure (TTF) - MBC Population

Apparent Terminal Half-Life (t1/2) of Serum Trastuzumab Emtansine

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Serum Trastuzumab Emtansine

AUCinf of Plasma DM1

AUCinf of Plasma Docetaxel

AUCinf of Total Serum Trastuzumab

CL of Plasma Docetaxel

CL of Total Serum Trastuzumab

Intervention	ng/mL (Mean)
	65 mg, Cycle 1 (n = 29)	65 mg, Cycle 2 (n = 24)	80 mg, Cycle 1 (n = 18)	80 mg, Cycle 2 (n = 17)
Phase Ib	1430	1280	1540	1590

Intervention	percentage of participants (Number)
Phase Ib Regimen 1	50.0
Phase Ib Regimen 2	70.0
Phase Ib Regimen 3	50.0
Phase Ib Regimen 4	66.7
Phase IIa Group A	47.6
Phase IIa Group B	52.4

Intervention	months (Median)
Phase Ib Regimen 1	11.7
Phase Ib Regimen 2	11.9
Phase Ib Regimen 3	11.3
Phase Ib Regimen 4	11.0
Phase IIa Group A	6.0
Phase IIa Group B	6.6

Intervention	day*mcg/mL (Mean)
	T-DM1	Total trastuzumab
Phase Ib Cohort 1	264	460
Phase Ib Cohort 3B	523	764
Phase Ib Cohort A	241	633
Phase Ib Cohort B	216	518
Phase Ib Cohort D	382	959
Phase Ib Cohort J	271	401

Intervention	participants (Number)
	T-DM1	Paclitaxel
Phase Ib Regimen 1	13	20
Phase Ib Regimen 2	5	7
Phase Ib Regimen 3	19	14
Phase Ib Regimen 4	2	3
Phase IIa Group A	15	18
Phase IIa Group B	12	19

Intervention	participants (Number)
	Any AEs	Any SAEs	Death	Any AEs Grade 3	Any AEs Grade 4	AEs leading to T-DM1 discontinuation	AEs leading to paclitaxel discontinuation	AEs leading to pertuzumab discontinuation
Phase Ib Regimen 1	26	7	1	19	0	3	20	NA
Phase Ib Regimen 2	10	5	0	5	2	1	7	1
Phase Ib Regimen 3	21	7	2	15	1	1	14	NA
Phase Ib Regimen 4	3	2	0	2	1	1	3	1
Phase IIa Group A	22	6	1	13	6	2	13	NA
Phase IIa Group B	22	6	1	13	2	0	13	0

Intervention	participants (Number)
	LVEF, increase	LVEF, 0 to <15%	LVEF, >=15 to <25%	LVEF, missing	New segmental wall abnormality
Phase Ib Regimen 1	8	17	0	1	0
Phase Ib Regimen 2	3	7	0	0	1
Phase Ib Regimen 3	5	14	2	0	0
Phase Ib Regimen 4	0	3	0	0	0
Phase IIa Group A	5	15	0	2	3
Phase IIa Group B	4	18	0	0	1

Intervention	percentage of participants (Number)
Trastuzumab + Taxane	61.8
Trastuzumab Emtansine + Placebo	50.9
Trastuzumab Emtansine + Pertuzumab	50.6

Intervention	percentage of participants (Number)
Trastuzumab + Taxane	75.0
Trastuzumab Emtansine + Placebo	66.9
Trastuzumab Emtansine + Pertuzumab	63.9

Intervention	percentage of participants (Number)
Trastuzumab + Taxane	51.8
Trastuzumab Emtansine + Placebo	52.9
Trastuzumab Emtansine + Pertuzumab	45.2