Recruiting
Phase 1

Observational Study

Sponsor:

Acerand Therapeutics (Hong Kong) Limited

Code:

NCT06801236

Conditions

Prostate Cancer (Adenocarcinoma)

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACE-232 tablets

Study Details

Brief 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)

Study ID

NCT06801236

Start date

May 12, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

88 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ACE-232

Administered once daily (QD) continuously at the assigned dose level in accordance with the standard 3+3 dose-escalation scheme

Interventions

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.

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 ]
  • Number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol [ Time Frame: From the first dose of ACE-232 on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (at the end of 28 days) ]
  • Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) [ Time Frame: Up to approximately 37 months ]

Central Contacts and Locations

Central contacts

Derek Yang, MD

86-13817816369derek.yang@acerand.com

Teresa Shi, MS

86-13916513539teresa.shi@acerand.com

Locations

University of California San Diego, Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Moffitt Cancer Center, Tampa

Recruiting

Tampa, Florida, United States, 33612

University of Maryland, Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Harvard Medical School-Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

M Health Fairview Clinics and Surgery Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Acerand Therapeutics (Hong Kong) Limited

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Acerand Therapeutics (Hong Kong) Limited on 2026-08-04.