Recent Updates
Recently added Catalysts

T-DM1

Phase 1

Breast Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jan 27, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

T-DM1 · 1 trial · 1 indication

Phase 1 1
NCT03032107A Study Of Pembrolizumab In Combination With Trastuzumab-DM1Breast Cancer
COMPLETED20 Analytics
PHASE1COMPLETED
A Study Of Pembrolizumab In Combination With Trastuzumab-DM1
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
21 days

The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE v4.0 will be used to identify a safe and tolerable dose

Secondary Endpoints

Objective Response Rate
2 years
Progression Free Survival
2 years
Duration Of Response
2 years
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pembrolizumab Combine With Trastuzumab EmtansineEXPERIMENTAL* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle * Pembrolizumab will be administered prior to T-DM1 administration * Pembrolizumab will be given at a predetermine dose * T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle * T-DM1 will be given at a predetermine dose

Interventions

NameTypeDescription
T-DM1DRUG-T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
PembrolizumabDRUG-Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evalua...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
Unlock Competitive Intelligence

Frequently asked questions about T-DM1

What is T-DM1 used for in breast cancer?

T-DM1 is an investigational small molecule being studied for the treatment of breast cancer. It is currently in Phase 1 clinical development. T-DM1 is being evaluated in combination with pembrolizumab in a clinical trial for patients with breast cancer.

Who makes T-DM1?

T-DM1 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical research on T-DM1 for the treatment of breast cancer.

What phase is T-DM1 in?

T-DM1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial of T-DM1 in combination with pembrolizumab for breast cancer has been completed.

What clinical trials is T-DM1 in?

T-DM1 has been studied in one clinical trial, identified as NCT03032107. This was a Phase 1 study titled "A Study Of Pembrolizumab In Combination With Trastuzumab-DM1" in patients with breast cancer. The trial enrolled 20 participants and has been completed.

Is T-DM1 the same as trastuzumab-DM1?

Yes, T-DM1 is also known as trastuzumab-DM1. The clinical trial NCT03032107 evaluated the combination of pembrolizumab with trastuzumab-DM1, which is the same drug as T-DM1, in patients with breast cancer.