A Study of HLD-0915 in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

• 1. Males of age 18 years at the time of signing the informed consent form (ICF).
• 2. Able to understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures.
• 3. Patients must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
• 4. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone.
• 5. Patients must have progressed on prior line(s) of therapy.
• 6. Patients must have progressive mCRPC defined as having demonstrated PSA progression on the prior regimen. PSA progression may have occurred with or without accompanying radiographic progression.
• 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• 8. Life expectancy of at least 3 months.
• 9. Adequate hematological, renal, and hepatic function.
• 10. Able to swallow an oral medication.
• 11. Willing and able to adhere to the study visit schedule and other protocol requirements.
• 12. Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to enrollment are eligible.
• 1. Has experienced a recent major bleed or has a known bleeding disorder.
• 2. Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology.
• 3. Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day.
• 4. Has received systemic anti-cancer therapy (cytotoxic chemotherapy, biologic agent, checkpoint inhibitors, or radiation therapy) or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods.
• 5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease.
• 6. Known clinically significant active or chronic infection.
• 7. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.