MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Nature and Objective:
MK-5684-01A substudy aims to evaluate the safety, tolerability, and preliminary efficacy of opevesostat (MK-5684), a CYP11A1 inhibitor, administered alone or in combination with other agents in patients with metastatic castration-resistant prostate cancer (mCRPC). The study includes a safety lead-in phase to determine the recommended Phase 2 dose (RP2D), followed by an efficacy phase assessing prostate-specific antigen (PSA) response and objective tumor response using standardized criteria.