Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
Start Date
5/12/2025
Completion Date
8/1/2028
Summary
This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).
Detailed Description
The study consists of two parts, Phase 1A dose escalation and Phase 1B dose optimization. Phase 1A aims to assess the safety, tolerability, pharmacokinetic (PK) profile, and changes in pharmacodynamic (PD) markers in patients treated with ACE-232, and to determine the maximum tolerated dose (MTD), if applicable. In Phase 1B, patients with AR gene alterations will be treated at two different dose levels to establish the recommended Phase 2 dose (RP2D).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ACE-232 tablets
Conditions
Locations
University of California San Diego, Moores Cancer Center
La Jolla, California 92093
United States
Moffitt Cancer Center, Tampa
Tampa, Florida 33612
United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United States
Harvard Medical School-Massachusetts General Hospital
Boston, Massachusetts 02114
United States
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota 55455
United States
Xcancer (Urology Cancer Center)
Omaha, Nebraska 68130
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States