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RecruitingInterventionalPhase 1

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)

NCT ID: NCT06801236Sponsor: Acerand Therapeutics (Hong Kong) LimitedLast updated: 2026-04-09

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).

Detailed description

The study consists of two parts, Phase 1A dose escalation and Phase 1B dose optimization. Phase 1A aims to assess the safety, tolerability, pharmacokinetic (PK) profile, and changes in pharmacodynamic (PD) markers in patients treated with ACE-232, and to determine the maximum tolerated dose (MTD), if applicable. In Phase 1B, patients with AR gene alterations will be treated at two different dose levels to establish the recommended Phase 2 dose (RP2D).

Arms & interventions

  • DrugACE-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.

Outcome measures

Primary

  • Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs)

    Number of patients with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc.

    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

    A DLT is defined as any toxicity events related to ACE-232 that occur from the first dose of study treatment until the planned end date of Cycle 1 (DLT assessment period), meeting the criteria specified in 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)

    RP2D will be finally determined by the SMC and sponsor based on all data from the dose escalation module and backfill module, as well as the exposure-response relationship evaluated (if available). MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.

    Time frame: Up to approximately 37 months

Secondary

  • Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to approximately 37 months

  • Pharmacokinetics characterization by using Maximum concentration (Cmax)

    Time frame: Up to approximately 37 months

  • Prostate Specific Antigen (PSA) response

    Time frame: Up to approximately 37 months

  • Objective Response Rate (ORR)

    Time frame: Up to approximately 37 months

  • Duration of Response (DoR)

    Time frame: Up to approximately 37 months

  • Radiographic Progression Free Survival (rPFS)

    Time frame: Up to approximately 37 months

  • Overall Survival (OS)

    Time frame: Up to approximately 37 months

  • Blood concentration of steroid hormone

    Time frame: Up to approximately 37 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (8)

University of California San Diego, Moores Cancer Center

La Jolla, California, 92093

Recruiting

Moffitt Cancer Center, Tampa

Tampa, Florida, 33612

Recruiting

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

Recruiting

Harvard Medical School-Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455

Recruiting

Xcancer (Urology Cancer Center)

Omaha, Nebraska, 68130

Recruiting

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

Recruiting

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

Recruiting