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Phase 1 Study of ACE-232 for Metastatic Castration-Resistant Prostate Cancer

This study is testing a new oral medication called ACE-232 for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to standard hormone therapy. You might be able to join if your cancer has progressed after at least one type of new hormonal agent and taxane-based chemotherapy. The main goals of this study are to find out how safe ACE-232 is, what side effects it might cause, and to determine the best dose to use in future studies. You would take ACE-232 tablets daily along with Dexamethasone and Fludrocortisone. The study is currently recruiting about 67 participants, but its exact status is unclear.

Study design
This is an open-label, Phase 1 study, meaning both you and your doctors will know which treatment you are receiving. It will enroll about 67 men.
What's involved
You will take ACE-232 tablets daily along with Dexamethasone and Fludrocortisone. You will continue treatment until your cancer progresses, you experience unacceptable side effects, or you choose to stop.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events for up to 30 days after your last dose, and for safety and dose information for up to approximately 37 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06801236

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Acerand Therapeutics (Hong Kong) Limited
~88 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:ACE-232 tablets

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs)
Measured over From time of information consent to 30 days post last dose, up to approximately 37 months
+2 more outcomes measured

Conditions

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

Explore related trials

Prostate Carcinoma

Where it's being run

9 sites across 9 states
California1
Florida1
Maryland1
Massachusetts1
Minnesota1
Nebraska1
South Carolina1
Washington1

Study leadership

  • Derek Yang, MD · STUDY_DIRECTOR · Acerand Therapeutics

Who to contact

Derek Yang, MD
[email protected]
86-13817816369
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

  • Number of patients experiencing dose limiting toxicity (DLT), as defined in the protocolFrom 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.

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