Actively Recruiting
Phase 1 Study of Valemetostat with Darolutamide to Treat Metastatic Castration-Resistant Prostate Cancer in Adult Men
Led by Daiichi Sankyo · Updated on 2026-05-15
60
Participants Needed
19
Research Sites
95 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of valemetostat in combination with darolutamide in adult males with Metastatic Castration Resistant Prostate Cancer mCRPC. This Phase 1, multicenter trial aims to understand how these drugs work together in this advanced prostate cancer form that continues to progress despite hormone therapy. The study includes two parts a dose escalation phase where valemetostat is given at increasing doses alongside a standard dose of darolutamide, and a dose expansion phase where valemetostat is administered at two or more dose levels with darolutamide. Participants receive these treatments to assess safety, tolerability, and preliminary efficacy. During the trial, participants are monitored from screening through approximately five years. Researchers will track dose-limiting toxicities, treatment-emergent adverse events, and various measures of prostate cancer activity including PSA response rates, radiographic progression-free survival, overall survival, and time to symptomatic bone events. Blood levels of valemetostat are also measured during treatment cycles to understand drug exposure and effects.
CONDITIONS
Brief Title
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Research Team
C
Contact for Trial Information
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