Phase 1b2a Study of Pocenbrodib Alone and With Darolutamide for Men With Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating pocenbrodib alone and in combination with darolutamide for treating metastatic castration-resistant prostate cancer mCRPC in patients who have progressed after prior therapies including anti-androgen treatments. This Phase 1b2a open-label study aims to confirm safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor effects of these treatments. It includes dose escalation, optimization, and dose expansion phases to find appropriate dosing levels and assess treatment effects in patients who have also received lutetium-Lu-177-vipivotide-tetraxetan PLUVICTO prior to taxane-based therapy. The study has two main phases Phase 1b involves dose escalation with three arms exploring different dosing schedules of pocenbrodib alone or combined with darolutamide to find the maximum tolerated dose and recommended Phase 2 doses. Phase 2a expands the study with two cohorts receiving different recommended doses of pocenbrodib combined with darolutamide. Treatments are given orally with varying dosing schedules including daily and twice-daily regimens, and safety is closely monitored throughout. Participants undergo regular assessments including safety evaluations, pharmacokinetic sampling during treatment cycles each 28 days, and tumor response evaluations. The primary outcomes focus on safety, tolerability, and efficacy measures such as radiographic progression-free survival and prostate-specific antigen changes. The study lasts through the treatment duration, estimated to be around six months for Phase 2a, with ongoing safety monitoring and data collection to understand drug behavior and patient response.

A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC