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

Open to males ages 18 years and up

• 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.