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)
Pathos AI, Inc.
Summary
This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with Abiraterone acetate, Olaparib or 177Lu-PSMA-617 in patients with metastatic castration-resistant prostrate cancer (mCRPC).
Description
This is a Phase 1b/2a multicenter, open-label study to confirm the safety, pharmacokinetics (PK), preliminary antitumor activity, and pharmacodynamics (PD) of pocenbrodib for the treatment of participants with mCRPC who have progressed despite prior therapy and have been treated with at least 1 potent anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide). The Phase 1b portion of the study involves pocenbrodib monotherapy at multiple, sequential five rising doses (50, 100, 150, 200, and 250mg) initially using a QD dosing schedule of 5 days on/2 days off. The f…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 darolu…
Interventions
- DrugPocenbrodib
Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.
- DrugCohort 2A (Pocenbrodib monotherapy), Cohort 2B (Pocenbrodib + abiraterone acetate), Cohort 2C (Pocenbrodib + olaparib), Cohort 2D (Pocenbrodib + 177Lu-PSMA-617
Pocenbrodib alone or in combination
Locations (18)
- MemorialCare Orange Coast Medical CenterFountain Valley, California
- Cancer and Blood Research CenterLos Alamitos, California
- University of Colorado HealthAurora, Colorado
- Mount Sinai Medical CenterMiami, Florida
- Emory University HospitalAtlanta, Georgia
- University of ChicagoChicago, Illinois