Tests ACE-232 tablets in men with advanced prostate cancer resistant to hormone therapy
Tests ACE-232 tablets for safety in adults with metastatic castration-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
Key facts
- Where
- Beijing, Fuzhou, Hangzhou, Shanghai, and Zhengzhou, ChinaSee the 5 sites
- Phase
- Phase 1
Where in China
- Beijing Gobroard HospitalBeijing, ChinaNot yet recruiting
- Fujian Cancer HospitalFuzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaNot yet recruiting
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Acerand Therapeutics (Hong Kong) Limited
- Trial code
- NCT06801236
- Record updated
- 25 September 2026
- Original 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).Read full original descriptionShow less
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)
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).
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; Any previous treatment-related toxicities have not recovered; Other malignancies requiring treatment within 3 years prior to the first dose of study drug; 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; 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; 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; Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.