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)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥18 years of age
• Histologic documentation of prostate adenocarcinoma
• Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable
Locations
United States
Colorado
University of Colorado Health
RECRUITING
Aurora
Florida
Mount Sinai Medical Center
RECRUITING
Miami
Michigan
Karmanos cancer institute
RECRUITING
Detroit
Missouri
Siteman Cancer Center
RECRUITING
St Louis
North Carolina
Duke University medical center
RECRUITING
Durham
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
Texas
Oncology Consultants, P.A
RECRUITING
Houston
Virginia
NEXT Oncology - Virginia
RECRUITING
Fairfax
Contact Information
Primary
Steve Kye, MD. MPH
steve.kye@pathos.com
708-232-3791
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 252
Treatments
Experimental: Phase 1 Portion
Dose level 1: 50 mg QD (5 days on/2 days off) Dose level 2: 100 mg QD (5 days on/2 days off) Dose level 3: 150 mg QD (5 days on/2 days off) Dose level 4: 200 mg QD (5 days on/2 days off) Dose level 5: 250 mg QD (5 days on/2 days off)
Experimental: Phase 2 portion
Phase 2 involves Pocenbrodib monotherapy and in combination with abiraterone acetate, olaprib or 177Lu-PSMA0617
Related Therapeutic Areas
Sponsors
Leads: Pathos AI, Inc.
Collaborators: Duke University