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

Part of paid clinical trials in La Jolla, California.

Sponsor
Acerand Therapeutics (Hong Kong) Limited
Study ID
NCT06801236
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACE-232 tablets — DRUG
    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.

Study Details

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 Dates

Start date
May 12, 2025
Status verified
Dec 2025
Primary completion
Mar 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ACE-232

Primary Outcome Measure

Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs) [ Time Frame: From time of information consent to 30 days post last dose, up to approximately 37 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California San Diego, Moores Cancer CenterLa JollaCalifornia92093-
Moffitt Cancer Center, TampaTampaFlorida33612-
University of Maryland, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Harvard Medical School-Massachusetts General HospitalBostonMassachusetts02114-
M Health Fairview Clinics and Surgery CenterMinneapolisMinnesota55455-
Xcancer (Urology Cancer Center)OmahaNebraska68130-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in La Jolla, CA

By research site
University of California San Diego, Moores Cancer Center· La Jolla, CAMoffitt Cancer Center, Tampa· Tampa, FLUniversity of Maryland, Greenebaum Comprehensive Cancer Center· Baltimore, MDHarvard Medical School-Massachusetts General Hospital· Boston, MAM Health Fairview Clinics and Surgery Center· Minneapolis, MNXcancer (Urology Cancer Center)· Omaha, NE

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