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)
Status: Recruiting
Location: See all (18) 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 darolutamide in patients with metastatic castration-resistant prostate 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
• Must have received at least 2 cycles of PLUVICTO®
• 1 line of prior any ARPI therapy
• No prior chemotherapy for mCRPC
Locations
United States
California
MemorialCare Orange Coast Medical Center
RECRUITING
Fountain Valley
Cancer and Blood Research Center
RECRUITING
Los Alamitos
Colorado
University of Colorado Health
RECRUITING
Aurora
Florida
Mount Sinai Medical Center
RECRUITING
Miami
Georgia
Emory University Hospital
RECRUITING
Atlanta
Illinois
University of Chicago
RECRUITING
Chicago
Indiana
Community Health Network
RECRUITING
Indianapolis
Louisiana
Ochsner
RECRUITING
Jefferson
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
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
Ohio
The Ohio State University
RECRUITING
Columbus
Taylor Cancer Research Center
RECRUITING
Maumee
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Oncology Consultants, P.A
RECRUITING
Houston
Virginia
NEXT Oncology - Virginia
RECRUITING
Fairfax
Contact Information
Primary
Steve Kye, MD, MPH
clinicaltrials@pathos.com
708-232-3791
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 120
Treatments
Experimental: Phase 1b Arm 1
Pocenbrodib 50-250 mg QD (5 days on/2 days off)
Experimental: Phase 1b Arm 2
Pocenbrodib 125-150 mg BID monotherapy
Experimental: Phase 1b Arm 3
Pocenbrodib 125-150 mg BID + darolutamide 600 mg
Experimental: Phase 2a portion
Cohort 1: pocenbrodib RP2D-high + darolutamide Cohort 2: pocenbrodib RP2D-low + darolutamide
Related Therapeutic Areas
Sponsors
Leads: Pathos AI, Inc.
Collaborators: Duke University