NCT06801236 · Acerand Therapeutics (Hong Kong) Limited
Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
What this study is about
This is an open label, phase I, multi-center study aiming to assess the safety and how well patients handle the treatment in patients with metastatic castration resistant prostate cancer (mCRPC).
View original scientific description
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).
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.
Primary outcome measures
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- La Jolla, California
- Tampa, Florida
- Baltimore, Maryland
- Boston, Massachusetts
- Minneapolis, Minnesota
- Omaha, Nebraska
- Myrtle Beach, South Carolina
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations