NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Inclusions/Exclusions: Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone. Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria. Have no known active or symptomatic central nervous system (CNS) disease. History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma). Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide.