Phase 1/2 Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Assessment of the safety and efficacy of HLD-0915 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) that have progressed on prior systemic therapies, once a recommended dose for expansion (RDE) has been determined in Phase 1 of the trial.
‣ All patients must meet the following criteria to be eligible for Phase 1 study participation:
• Males of age 18 years at the time of signing the informed consent form (ICF).
• Able to understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures.
• Patients must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
• Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone.
• Patients must have progressed on prior line(s) of therapy.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy of at least 3 months.
• Adequate hematological, renal, and hepatic function.
⁃ Able to swallow an oral medication.
⁃ Willing and able to adhere to the study visit schedule and other protocol requirements.
⁃ Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to enrollment are eligible.