A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria: * histologically confirmed diagnosis of metastatic CRPC * standard of care androgen deprivation treatment * castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L) * progressive disease while receiving androgen deprivation therapy * previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria * adequate hematologic, renal and hepatic function * KPS of ≥ 70 or ECOG of 0 to 1 Exclusion Criteria: * pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology * use of opiate analgesics for prostate cancer pain within 4 week of treatment start * more than one sequential second generation AR-directed therapy * received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks * history of bleeding disorder * history of seizure disorder * concomitant use of therapeutic anticoagulation * history of or current cardiac issues * received external beam radiation therapy within 4 weeks * CTCAE Grade \> 2 neuropathy