Actively Recruiting
Phase 1b/2a Open-Label Study of Pocenbrodib Alone or with Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Men with Metastatic Castration-Resistant Prostate Cancer
Led by Pathos AI, Inc. · Updated on 2026-04-24
252
Participants Needed
18
Research Sites
43 weeks
Total Duration
On this page
Sponsors
P
Pathos AI, Inc.
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
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 1b/2a 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 treatment's effects.
CONDITIONS
Brief Title
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologic confirmation of prostate adenocarcinoma
- Metastatic disease confirmed by imaging within 56 days before screening
You will not qualify if you...
- Evidence of small cell or neuroendocrine prostate cancer on recent biopsy
- Liver metastases confirmed by biopsy or lesions larger than 1 cm on imaging
- Treatment with chemotherapy, investigational agents, or certain antiandrogen drugs within 14 days before screening or five half-lives, whichever is shorter
- Serious medical, psychiatric, psychological, familial, or geographical conditions that may interfere with participation or increase treatment risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple 28-day cycles during Phase 1b
Participants receive escalating doses of pocenbrodib monotherapy to determine safety and appropriate dosing.
Visits occur at the end of each 28-day cycle for safety and pharmacokinetic assessments
Duration - Up to approximately 6 months or until disease progression or unacceptable toxicity
Participants receive pocenbrodib alone or in combination with abiraterone acetate, olaparib, or 177Lu-PSMA-617 depending on cohort assignment, with dosing schedules of 5 days on followed by 2 days off each week.
Regular visits throughout treatment for dosing, safety, and efficacy evaluations
Duration - Up to approximately 32 months from first dose
Participants are monitored for overall survival and long term safety after treatment ends.
Periodic visits for survival and safety assessments
Trial Site Locations
Total: 18 locations
1
MemorialCare Orange Coast Medical Center
Fountain Valley, California, United States, 92708
Actively Recruiting
2
Cancer and Blood Research Center
Los Alamitos, California, United States, 90720
Actively Recruiting
3
University of Colorado Health
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Mount Sinai Medical Center
Miami, Florida, United States, 33140
Actively Recruiting
5
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Community Health Network
Indianapolis, Indiana, United States, 46250
Actively Recruiting
8
Ochsner
Jefferson, Louisiana, United States, 70121
Actively Recruiting
9
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Siteman Cancer Center
St Louis, Missouri, United States, 63108
Actively Recruiting
12
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
13
Duke University medical center
Durham, North Carolina, United States, 27710
Actively Recruiting
14
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
15
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
16
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
17
Oncology Consultants, P.A
Houston, Texas, United States, 77030
Actively Recruiting
18
NEXT Oncology - Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Steve Kye, MD. MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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