PATHWAY: A Phase 1b/2a, Multicenter, Open- Label Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide 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 darolutamide in patients with metastatic castration-resistant prostate 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 following prior therapy and have been treated with at least 1 potent anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide). Phase 1b is a dose escalation and optimization study of pocenbrodib monotherapy and in combination with darolutamide in order to determine the maximum tolerated dose (MTD) in participants (n=80) and to det…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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,…
Interventions
- DrugPocenbrodib
Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.
- DrugPocenbrodib and Darolutamide
Pocenbrodib in combination with darolutamide
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