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NCT Number: NCT06801236

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

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).

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Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms mCRPC (Metastatic Castration-resistant Prostate Cancer)

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of California San Diego, Moores Cancer Center, La Jolla, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

  2. 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)

    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.

  3. Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD)

    Time frame: Up to approximately 37 months

    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.

Secondary outcomes

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

    Time frame: Up to approximately 37 months

    To determine the pharmacokinetics (PK) using AUC of ACE-232 after a single dose and at steady state after multiple doses.

  2. Pharmacokinetics characterization by using Maximum concentration (Cmax)

    Time frame: Up to approximately 37 months

    To determine the pharmacokinetics (PK) using Cmax of ACE-232 after a single dose and at steady state after multiple doses

  3. Prostate Specific Antigen (PSA) response

    Time frame: Up to approximately 37 months

    PSA response is defined as PSA decline of 30% and 50% from baseline at any time point

  4. Objective Response Rate (ORR)

    Time frame: Up to approximately 37 months

    ORR is defined as a complete response (CR) or partial response (PR), as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) and Prostate Cancer Working Group Criteria 3 (PCWG3 criteria), in patients with measurable disease at baseline.

  5. Duration of Response (DoR)

    Time frame: Up to approximately 37 months

    DOR is defined, for patients with an objective response, as the time from first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause.

  6. Radiographic Progression Free Survival (rPFS)

    Time frame: Up to approximately 37 months

    rPFS is defined as the time from the first dose of ACE-232 to the first documented disease progression by either RECIST progression and/or progression on bone scan by PCWG3 or death due to any cause, whichever occurs first.

  7. Overall Survival (OS)

    Time frame: Up to approximately 37 months

    OS is defined as the time from the first dose of ACE-232 to the date of death due to any cause.

  8. Blood concentration of steroid hormone

    Time frame: Up to approximately 37 months

    To determine the blood concentration of steroid hormones at various timepoints and change from baseline

Other outcomes

  1. Gene aberrations

    Time frame: Up to approximately 37 months

    To determine the gene aberrations in circulating tumor DNA (ctDNA), and its association with tumor response or resistance to ACE-232

Study contacts

Contact information is provided by the study sponsor or research team.

Sherwin Cai, MD

CONTACT

[email protected]

86-18983021726

Teresa Shi, MS

CONTACT

[email protected]

86-13916513539

Sponsors and collaborators

Lead sponsor

Acerand Therapeutics (Hong Kong) Limited

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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