Actively Recruiting
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
Eligibility Criteria
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
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
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
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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