Study of Pocenbrodib for Metastatic Castration-Resistant Prostate Cancer
This study is testing a new drug called pocenbrodib, both alone and with an existing drug called darolutamide, for men with metastatic castration-resistant prostate cancer (mCRPC). mCRPC is prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy. The main goals are to find a safe dose of pocenbrodib and to see how well it works. You might be able to join if you are at least 18 years old, have prostate cancer that has spread, and have already received certain anti-androgen therapies. The study will look at how safe the treatments are and if they help shrink the cancer.
- Study design
- This is a Phase 1b/2a study, meaning it's an early-stage trial to find the right dose and check for safety and initial effectiveness. It plans to enroll 120 participants and is an open-label study, so you and your doctors will know which treatment you are receiving.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability will be assessed throughout the duration of treatment, estimated for 6 months in Phase 2a.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
At a glance
Conditions
Where it's being run
19 sites across 16 statesWho to contact
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What this trial measures
- Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide28 days
Occurrence and severity of Serious Adverse Events (SAEs) and clinically relevant Adverse Events (AEs), and clinically significant changes in safety laboratory values and electrocardiograms (ECGs)
- Phase 1b: Identify the recommended Phase 2 doses of pocenbrodib and in combination with darolutamide28 days
Frequency and type of DLTs used to determine the maximum tolerated dose (MTD) and RP2Ds
- Phase 2a: Assess the safety and tolerability of the RP2Ds of pocenbrodib in combination with darolutamideThrough duration of treatment, estimated 6 months
1. Occurrence and severity of SAEs, clinically relevant AEs, and clinically significant changes in safety laboratory values, physical examination (PE) findings, vital signs, and ECGs. 2. Safety and selection of pocenbrodib RP2D for combination with darolutamide for subsequent development
- Phase 2a: Evaluate the efficacy of RP2Ds of pocenbrodib in combination with darolutamideThrough duration of treatment, estimated 6 months.
Post-177Lu-PSMA-617 (Post-PLUVICTO®) pre-taxane mCRPC: Radiographic progression-free survival (rPFS), assessed as time from randomization to first occurrence of Radiographic progression-free survival (rPFS) according to; i) Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and ii) Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever comes first.