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

NCT06801236 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-04-09

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Acerand Therapeutics (Hong Kong) Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2028-03-01
Completion
2028-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06801236 on ClinicalTrials.gov