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

Recruiting now · Phase 1

Conditions studied: Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer)

In brief

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).

Key facts

Study ID

NCT06801236

Run by

Acerand Therapeutics (Hong Kong) Limited

People needed

88

Starts

2025-05-12

Expected to finish

2028-12-31

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
• Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong the QT interval.
• Any previous treatment-related toxicities have not recovered.
• Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.
• Severe cardiovascular disorders.
• Known gastrointestinal (GI) disorder or GI procedure
• History of gastric and duodenal perforation.
• History of pituitary dysfunction.
• Poorly controlled diabetes mellitus.
• Active or uncontrolled autoimmune disease
• Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
• Other malignancies requiring treatment within 3 years prior to the first dose of study drug
• Known allergy or hypersensitivity to any of the excipients of ACE-232.
• Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.

Where it is running

• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Moffitt Cancer Center, Tampa — Tampa, Florida, United States (enrolling)
• University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
• Harvard Medical School-Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• M Health Fairview Clinics and Surgery Center — Minneapolis, Minnesota, United States (enrolling)
• University of California San Diego, Moores Cancer Center — La Jolla, California, United States (enrolling)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
• Xcancer (Urology Cancer Center) — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.