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