Evaluating Pocenbrodib for advanced prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label study aims to assess the safety and preliminary antitumor activity of Pocenbrodib, both alone and in combination with other therapies such as Abiraterone acetate, Olaparib, or 177Lu-PSMA-617, in patients with metastatic castration-resistant prostate cancer (mCRPC). The study is structured in two phases: Phase 1b focuses on dose-finding for Pocenbrodib monotherapy, while Phase 2a evaluates its efficacy in combination with other treatments. Participants must have progressed despite prior therapies and have received at least one potent anti-androgen treatment. The study will monitor safety, pharmacokinetics, and pharmacodynamics to determine the best treatment approach.

Why it matters

Who can join: the full rules

1b / 2a Inclusion Criteria:

1. ≥18 years of age
2. Histologic documentation of prostate adenocarcinoma
3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable

1b / 2a Exclusion Criteria:

1. Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy.
2. Any liver metastases confirmed by biopsy or evidence of lesions \>1 cm consistent with liver metastases on imaging.
3. Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Cycle 1 Day 1 or 5 half-lives (whichever is shorter).
4. Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complications.

2a only -key inclusion criteria:

1. Must have received at least 2 cycles of PLUVICTO®
2. 1 line of prior any ARPI therapy
3. No prior chemotherapy for mCRPC

Where it's running

• MemorialCare Orange Coast Medical Center
  Fountain Valley, California, United States Recruiting
• Cancer and Blood Research Center
  Los Alamitos, California, United States Recruiting
• University of Colorado Health
  Aurora, Colorado, United States Recruiting
• Mount Sinai Medical Center
  Miami, Florida, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Steve Kye, MD, MPH
• Email: clinicaltrials@pathos.com
• Phone: 708-232-3791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.