Testing ACE-232 for advanced prostate cancer treatment
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)
This study is testing a new treatment called ACE-232 to see if it is safe and effective for people with advanced prostate cancer that has not responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Acerand Therapeutics Limited Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 8 sites (La Jolla, California and 7 other locations) |
| Trial ID | NCT06801236 on ClinicalTrials.gov |
What this trial studies
This open-label, phase 1 study evaluates the safety and tolerability of ACE-232 in patients with metastatic castration-resistant prostate cancer (mCRPC). It consists of two parts: Phase 1A focuses on dose escalation to determine the maximum tolerated dose, while Phase 1B treats patients with AR gene alterations at different dose levels to establish the recommended Phase 2 dose. The study also assesses pharmacokinetics and pharmacodynamics to understand the drug's effects better.
Who should consider this trial
Good fit: Ideal candidates include men with metastatic castration-resistant prostate cancer who have undergone prior treatments and are suitable for investigational therapies.
Not a fit: Patients with spinal cord compression, known brain metastases, or those currently receiving other anti-cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat mCRPC.
How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced prostate cancer, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
La Jolla, California and 7 other locations
- University of California San Diego, Moores Cancer Center — La Jolla, California, United States (Recruiting)
- Moffitt Cancer Center, Tampa — Tampa, Florida, United States (Recruiting)
- University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
- Harvard Medical School-Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- M Health Fairview Clinics and Surgery Center — Minneapolis, Minnesota, United States (Recruiting)
- Xcancer (Urology Cancer Center) — Omaha, Nebraska, United States (Recruiting)
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (Recruiting)
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Sherwin Cai, MD
- Email: sherwin.cai@acerand.com
- Phone: 86-18983021726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.