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NOT YET RECRUITING
NCT07908524
PHASE1/PHASE2

MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer/androgen pathway modulator refractory (mCRPC/APMR). Current treatment for mCRPC includes chemotherapy, such as docetaxel. Chemotherapy is medicine that works to destroy cancer cells or stop them from growing. In this trial, researchers want to learn if giving sacituzumab tirumotecan (sac-TMT) alone or with other treatments can treat mCRPC. Sac-TMT is a trial medicine that is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. Opevesostat is another trial medicine designed to block the body from making steroid hormones that cause the cancer cells to grow. The goals of this trial are to learn: * How many participants have the cancer respond (gets smaller or goes away) to the trial treatments * About the safety of the trial treatments and if participants tolerate the treatments. Tolerate means participants will receive the trial treatments unless they need to stop it due to health problems.

Official title: MK-2870-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2870-U01 Master Protocol to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan (Sac-TMT; MK-2870) Alone or in Combination for the Treatment of Participants With Metastatic Castration-Resistant Prostate Cancer/Androgen Pathway Modulator Refractory (mCRPC/APMR)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2026-12-14

Completion Date

2032-06-29

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

IV infusion

DRUG

Rescue medication

Participants receiving sac-TMT may be administered the following rescue medications according to the approved product: granulocyte colony-stimulating factor, histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

DRUG

Docetaxel

IV infusion

DRUG

Prednisone

Oral administration

DRUG

Opevesostat

Oral administration

DRUG

Abiraterone acetate

Oral administration

DRUG

Enzalutamide

Oral administration

DRUG

Prednisolone

Oral administration

DRUG

Fludrocortisone

Oral administration

DRUG

Dexamethasone

Oral administration