A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorPathos AI, Inc.
About this trial
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)
Eligibility criteria
Qualifiers
≥18 years of age
Histologic documentation of prostate adenocarcinoma
Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable
Disqualifiers
Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy.
Any liver metastases confirmed by biopsy or evidence of lesions >1 cm consistent with liver metastases on imaging.
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).
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.
Trial design
Treatments tested in this trial
- Pocenbrodib
- Pocenbrodib and Darolutamide
Treatment groups
120 Participants
are divided into 4 treatment groupsSponsors and collaborators
Pathos AI, Inc.
Lead sponsor
Duke University
Collaborator
Source ClinicalTrials.gov