Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT06801236
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
67 participants
INTERVENTIONAL
2025-05-12
2028-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ACE-232
ACE-232 tablets
ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Interventions
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ACE-232 tablets
ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Acerand Therapeutics (Hong Kong) Limited
INDUSTRY
Responsible Party
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Locations
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University of California San Diego, Moores Cancer Center
La Jolla, California, United States
Moffitt Cancer Center, Tampa
Tampa, Florida, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Harvard Medical School-Massachusetts General Hospital
Boston, Massachusetts, United States
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, United States
Xcancer (Urology Cancer Center)
Omaha, Nebraska, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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ACE-232-001
Identifier Type: -
Identifier Source: org_study_id