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A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC

NCT06785636

RecruitingPhase 1, Phase 2

Sponsor: Pathos AI, Inc.

Conditions: mCRPC (Metastatic Castration-resistant Prostate Cancer), Prostate Cancer

Interventions: Pocenbrodib, Pocenbrodib and Darolutamide

Countries: United States

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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, or darolutamide, 14 days prior to Cycle 1 Day 1 or 5 half-lives (whichever is shorter).
4. 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.

2a only -key inclusion criteria:

1. Must have received at least 2 cycles of PLUVICTO®
2. 1 line of prior any ARPI therapy
3. No prior chemotherapy for mCRPC
Locations (19)
  • Fountain Valley, California, United States
  • Los Alamitos, California, United States
  • Aurora, Colorado, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Jefferson, Louisiana, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Columbus, Ohio, United States
  • Maumee, Ohio, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Fairfax, Virginia, United States