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MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)
Sponsor: Merck Sharp & Dohme LLC
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
Sacituzumab tirumotecan
IV infusion
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).
Docetaxel
IV infusion
Prednisone
Oral administration
Opevesostat
Oral administration
Abiraterone acetate
Oral administration
Enzalutamide
Oral administration
Prednisolone
Oral administration
Fludrocortisone
Oral administration
Dexamethasone
Oral administration