RecruitingPhase 1NCT06801236

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

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)

Sponsor

Acerand Therapeutics (Hong Kong) Limited

Enrollment

67 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)

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).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing a new drug called ACE-232 in men with metastatic castration-resistant prostate cancer — cancer that has spread and no longer responds to hormone-blocking therapy or standard chemotherapy. **You may be eligible if...** - You have prostate cancer that has spread and is no longer controlled by hormone therapy - You have already tried at least one hormonal agent and one taxane-based chemotherapy - You are in good general health (ECOG score 0 or 1) - Your life expectancy is at least 6 months - Your organ and bone marrow function are adequate **You may NOT be eligible if...** - You are currently on other anti-cancer treatment - You have untreated brain metastases - You have a serious active infection or autoimmune disease - You have recently had a heart attack or stroke Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGACE-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.