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)

Acerand Therapeutics (Hong Kong) Limited

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).

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

Age range: 18+ years
Sex: Male
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Provide written informed consent * Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy * Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment; * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has a life expectancy of at least 6 months * Adequate organ function and bone marrow function Exclusion Criteria: * Receiving any anti-cancer drugs or other treatme…

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
Moffitt Cancer Center, Tampa
Tampa, Florida
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland
Harvard Medical School-Massachusetts General Hospital
Boston, Massachusetts
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota
Xcancer (Urology Cancer Center)
Omaha, Nebraska