Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer

Inclusion Criteria: 1. Men aged 18 years and older. 2. Histologically confirmed diagnosis of prostate cancer 3. Castrate level of testosterone in blood serum \< 1,7 nmol/l or \< 50 ng/dl 4. PSA level at screening \> 2 ng/ml 5. Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy. 6. The patient's ECOG performance status of 0 - 2 7. Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC 8. The expected survival time of not less than 12 weeks Exclusion Criteria: 1. Prior anticancer therapy: * Treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ II grade according to CTCAE scale, related to prior anticancer therapy (excluding alopecia) * Prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening * Exposure to bisphosphonates is allowed only if the treatment started prior to screening 2. Clinically significant cardiovascular system diseases: 3. Clinically significant central nervous system diseases: 4. History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus) 5. Prior or concomitant therapy: * Exposure to drugs which may cause a convulsive state within 4 weeks prior to screening * Exposure to treatment with characteristics of CYP3A4 or CYP2D6 inhibitors within 4 weeks prior to screening * Exposure to treatment relating to the Class I risk of QT-interval prolongation; exposure to treatment relating to the Class II risk of QT-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment