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RECRUITING
NCT06801236
PHASE1

Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor: Acerand Therapeutics (Hong Kong) Limited

View on ClinicalTrials.gov

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).

Official title: A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2025-05-12

Completion Date

2028-08-01

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

ACE-232 tablets

ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Locations (8)

University of California San Diego, Moores Cancer Center

La Jolla, California, United States

Moffitt Cancer Center, Tampa

Tampa, Florida, United States

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Harvard Medical School-Massachusetts General Hospital

Boston, Massachusetts, United States

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, United States

Xcancer (Urology Cancer Center)

Omaha, Nebraska, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States