Testing ACE-232 for advanced prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Carolina Urologic Research Center
  Myrtle Beach, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Derek Yang, MD
• Email: derek.yang@acerand.com
• Phone: 86-13817816369

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer

  This study tests whether FX-111 is safe and can help treat metastatic castration-resistant prostate cancer in adult men.

  Recruiting at 7 sites Phase 1 Flare Therapeutics Inc. · Los Angeles, California and 9 other locations · NCT07719361

• Talazoparib with or without enzalutamide for people with HRR-mutant mCRPC after abiraterone

  This will see if adding enzalutamide to talazoparib, or using talazoparib alone, can slow cancer progression in people with HRR-mutant metastatic castration-resistant prostate cancer who have already taken abiraterone.

  Recruiting at 8 sites Phase 2 Prostate Cancer Clinical Trials Consortium · Duarte, California and 7 other locations · NCT06844383

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback

  Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.

  Recruiting at 4 sites Shanghai Zhongshan Hospital · Shanghai and 3 other locations · NCT07856017

• MRT-2359 plus apalutamide in advanced prostate cancer

  This Phase 2 trial tests whether taking MRT-2359 with apalutamide can lower PSA in men with castration-resistant prostate cancer.

  Recruiting at 7 sites Phase 2 Monte Rosa Therapeutics, Inc · Los Angeles, California and 13 other locations · NCT07745361

• Predicting prostate cancer response to neoadjuvant darolutamide with a gene biomarker

  This study tests whether a gene-based PCAI ImmunoScore can predict which high-risk localized or locally advanced prostate cancer patients will have minimal residual disease after 90–120 days of darolutamide before surgery.

  Recruiting at 2 sites Phase 2 Region Stockholm · Gothenburg and 1 other locations · NCT07617272

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.