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Sacituzumab Tirumotecan (Sac-TMT)

DRUG8 trials

Sponsors

Merck Sharp & Dohme LLC, Fudan University, Peking Union Medical College Hospital, National Cancer Center, Japan, Xiaorong Dong

Conditions

Adjuvant Drug TherapyBrain Metastases From Non-small Cell Lung Cancer (NSCLC)Brain MetastasisEGFR Mutation Positive Advanced Non-Small Cell Lung CancerEsophageal CancerEsophageal NeoplasmsGastroesophageal AdenocarcinomaGastroesophageal Junction

Phase 1

Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
RecruitingNCT06469944
Merck Sharp & Dohme LLCGastroesophageal Junction, Gastroesophageal Adenocarcinoma, Esophageal Neoplasms +1
Start: 2024-09-20End: 2029-09-12Target: 160Updated: 2026-09-02

Phase 2

KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
RecruitingNCT07252739
Merck Sharp & Dohme LLCMalignant Neoplasm
Start: 2025-12-19End: 2032-05-31Target: 140Updated: 2026-09-02
Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases
RecruitingNCT07623577
Fudan UniversityTNBC, Brain Metastasis
Start: 2026-01-01End: 2027-12-01Target: 24Updated: 2026-06-03
SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological Malignancies
Not yet recruitingNCT07738757
Peking Union Medical College HospitalRecurrent or Metastatic MSI-H/dMMR Gynecological Malignancies
Start: 2026-09-01End: 2029-12-30Target: 80Updated: 2026-07-31
A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Treated Unresectable Thymic Carcinomas
Not yet recruitingNCT07750353
National Cancer Center, JapanUnresectable Thymic Carcinoma
Start: 2027-02-01End: 2030-06-01Target: 35Updated: 2026-08-06
Sacituzumab Tirumotecan（Sac-TMT） and Brain Radotherapy for EGFR+ NSCLC With Brain Mets
Not yet recruitingNCT07789444
Xiaorong DongNon-Small Cell Lung Cancer, Brain Metastases From Non-small Cell Lung Cancer (NSCLC), EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
Start: 2026-08-30End: 2028-12-01Target: 53Updated: 2026-08-27
Sac-TMT in Vaginal and Vulvar Cancers
Not yet recruitingNCT07804966
Latin American Cooperative Oncology GroupVaginal Squamous Cell Carcinoma, Vulvar Squamous Cell Carcinoma
Start: 2027-01-01End: 2032-01-01Target: 48Updated: 2026-09-04

Phase 3

Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations
Not yet recruitingNCT07628504
Fudan UniversityAdjuvant Drug Therapy
Start: 2026-05-18End: 2035-03-30Target: 420Updated: 2026-06-05

Related Papers

KEYMAKER-U01J: Calderasib plus pembrolizumab with or without cetuximab as first-line treatment for advanced or metastatic nonsquamous non–small-cell lung cancer (NSCLC) with <i>KRAS</i> G12C mutations.
Journal of Clinical Oncology2026-05-28
KEYMAKER-U06: Phase 1/2 umbrella platform study of TROP2 antibody-drug conjugate sacituzumab tirumotecan plus pembrolizumab plus chemotherapy (substudy 06C) and sacituzumab tirumotecan plus paclitaxel (substudy 06D) in gastroesophageal adenocarcinoma.
Journal of Clinical Oncology2025-01-27