RECRUITING

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

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Conditions

Prostate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)ACE-232castration-resistant prostate cancerCRPCHormone AntagonistsHormone SubstitutesAntineoplastic AgentsProstatic NeoplasmsCastration-Resistantprostate cancerCYP11A1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2025-05-12
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06801236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide written informed consent
  2. * Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy
  3. * 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;
  4. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. * Has a life expectancy of at least 6 months
  6. * Adequate organ function and bone marrow function
  1. * Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
  2. * 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.
  3. * Any previous treatment-related toxicities have not recovered.
  4. * Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.
  5. * Severe cardiovascular disorders.
  6. * Known gastrointestinal (GI) disorder or GI procedure
  7. * History of gastric and duodenal perforation.
  8. * History of pituitary dysfunction.
  9. * Poorly controlled diabetes mellitus.
  10. * Active or uncontrolled autoimmune disease
  11. * Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
  12. * Other malignancies requiring treatment within 3 years prior to the first dose of study drug
  13. * Known allergy or hypersensitivity to any of the excipients of ACE-232.
  14. * Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.

Contacts and Locations

Study Contact

Sherwin Cai, MD
CONTACT
86-18983021726
sherwin.cai@acerand.com
Teresa Shi, MS
CONTACT
86-13916513539
teresa.shi@acerand.com

Study Locations (Sites)

University of California San Diego, Moores Cancer Center
La Jolla, California, 92093
United States
Moffitt Cancer Center, Tampa
Tampa, Florida, 33612
United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
Harvard Medical School-Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455
United States
Xcancer (Urology Cancer Center)
Omaha, Nebraska, 68130
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Acerand Therapeutics (Hong Kong) Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2025-05-12
Study Completion Date2028-08-01

Terms related to this study

Keywords Provided by Researchers

  • ACE-232
  • castration-resistant prostate cancer
  • CRPC
  • Hormone Antagonists
  • Hormone Substitutes
  • Antineoplastic Agents
  • Prostatic Neoplasms
  • Castration-Resistant
  • prostate cancer
  • CYP11A1

Additional Relevant MeSH Terms

  • Prostate Cancer (Adenocarcinoma)
  • mCRPC (Metastatic Castration-resistant Prostate Cancer)