Evaluating Pocenbrodib for advanced prostate cancer treatment
A Phase 1b/2a, MultiCenter, Open- Label Study of Pocenbrodib as Monotherapy or in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This study is testing a new drug called Pocenbrodib, alone and with other treatments, to see if it can help people with advanced prostate cancer who haven't responded to previous therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Pathos AI, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 18 sites (Fountain Valley, California and 17 other locations) |
| Trial ID | NCT06785636 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older with histologically confirmed metastatic prostate adenocarcinoma who have progressed after prior anti-androgen therapy.
Not a fit: Patients with small cell or neuroendocrine prostate cancer, liver metastases, or those who have recently received certain cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced prostate cancer who have limited alternatives.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating mCRPC, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key 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 Key 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 Screening or 5 half-live20. 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 complicationss from the last dose (whichever is shorter)
Where this trial is running
Fountain Valley, California and 17 other locations
- 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)
- Community Health Network — Indianapolis, Indiana, United States (Recruiting)
- Ochsner — Jefferson, Louisiana, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Siteman Cancer Center — St Louis, Missouri, United States (Recruiting)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (Recruiting)
- Duke University medical center — Durham, North Carolina, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Taylor Cancer Research Center — Maumee, Ohio, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Oncology Consultants, P.A — Houston, Texas, United States (Recruiting)
- NEXT Oncology - Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Steve Kye, MD. MPH
- Email: clinicaltrials@pathos.com
- Phone: 708-232-3791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.