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 groups

Locations

18
California
MemorialCare Orange Coast Medical Center92708, Fountain Valley United States
Cancer and Blood Research Center90720, Los Alamitos United States
Colorado
University of Colorado Health80045, Aurora United States
Florida
Mount Sinai Medical Center33140, Miami United States

Sponsors and collaborators

Pathos AI, Inc.

Lead sponsor

Duke University

Collaborator