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

Eligibility 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
• * 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.