Phase 1b2a Open-Label Study of Pocenbrodib Alone or with Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Men with Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of pocenbrodib, alone or combined with abiraterone acetate, olaparib, or 177Lu-PSMA-617, in men with metastatic castration-resistant prostate cancer mCRPC who have progressed after prior therapies including at least one potent anti-androgen treatment. This Phase 1b2a open-label study aims to find an appropriate dose and assess early treatment effects in this population. The Phase 1b part tests five increasing doses of pocenbrodib monotherapy 50, 100, 150, 200, and 250 mg given once daily for 5 days followed by 2 days off. Participants start at the lowest dose with careful safety monitoring before moving to higher doses. If safety and minimum efficacy are demonstrated, Phase 2a begins, enrolling four groups pocenbrodib alone, or combined with abiraterone acetate, olaparib, or 177Lu-PSMA-617. These groups run simultaneously but are evaluated separately. Participants will have regular assessments including imaging and prostate-specific antigen PSA tests to measure treatment response and progression. Safety and dose-limiting toxicities are closely tracked over 28-day cycles. Pharmacokinetic measures like plasma drug concentrations and half-life will be recorded. The study period extends up to about 32 months, with outcomes such as tumor response, progression-free survival, and overall survival monitored to understand the treatments effects.

Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617