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Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06801236 · Acerand Therapeutics Limited
In plain English
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Official 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)
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).
Eligibility criteria
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 target: 67 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-12
Estimated completion: 2028-08-01
Last updated: 2026-04-09
Interventions
Drug: ACE-232 tablets
Primary outcomes
- • 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 experiencing dose limiting toxicity (DLT), as defined in the protocol (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) (Up to approximately 37 months)
Sponsor
Acerand Therapeutics (Hong Kong) Limited · industry
Contacts & investigators
ContactSherwin Cai, MD · contact · sherwin.cai@acerand.com · 86-18983021726
ContactTeresa Shi, MS · contact · teresa.shi@acerand.com · 86-13916513539
All locations (8)
University of California San Diego, Moores Cancer CenterRecruiting
La Jolla, California, United States
Moffitt Cancer Center, TampaRecruiting
Tampa, Florida, United States
University of Maryland, Greenebaum Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Harvard Medical School-Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
M Health Fairview Clinics and Surgery CenterRecruiting
Minneapolis, Minnesota, United States
Xcancer (Urology Cancer Center)Recruiting
Omaha, Nebraska, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States