Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT06801236

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

Led by Acerand Therapeutics (Hong Kong) Limited · Updated on 2026-04-09

67

Participants Needed

8

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent
  • Have metastatic castration-resistant prostate cancer with ongoing androgen deprivation therapy or bilateral orchiectomy
  • Have difficult-to-treat or intolerant disease after at least one line of novel hormonal agent and taxane-based chemotherapy in metastatic hormone-sensitive or resistant prostate cancer
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have a life expectancy of at least 6 months
  • Have adequate organ and bone marrow function
Not Eligible

You will not qualify if you...

  • Receiving anti-cancer drugs, major surgery, or extensive radiation therapy within protocol-defined wash-out periods
  • Using medications or supplements that strongly affect CYP3A4 or P-gp or prolong QT interval
  • Have unresolved toxicities from previous treatments
  • Have spinal cord compression, brain metastases, or leptomeningeal carcinomatosis
  • Have severe cardiovascular disorders
  • Have known gastrointestinal disorders or history of gastric or duodenal perforation
  • Have history of pituitary dysfunction
  • Have poorly controlled diabetes mellitus
  • Have active or uncontrolled autoimmune disease
  • Have active infections or known HIV, hepatitis B or C, or tuberculosis
  • Have other cancers requiring treatment within 3 years before study drug
  • Have allergy to ACE-232 ingredients
  • Have medical conditions interfering with safety, efficacy, or treatment compliance as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

University of California San Diego, Moores Cancer Center

La Jolla, California, United States, 92093

Actively Recruiting

2

Moffitt Cancer Center, Tampa

Tampa, Florida, United States, 33612

Actively Recruiting

3

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

4

Harvard Medical School-Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

5

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

6

Xcancer (Urology Cancer Center)

Omaha, Nebraska, United States, 68130

Actively Recruiting

7

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

8

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

S

Sherwin Cai, MD

CONTACT

T

Teresa Shi, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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