Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients

Inclusion Criteria

• •1. Signed informed consent provided prior to any study-related procedure being performed;
• •2. Able to swallow and retain orally administered medication;
• •3. Male aged 18 years and older;
• •4. diagnosis of prostate carcinoma;
• •5. Men with either non-metastatic or metastatic CRPC are eligible;
• •6. Completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for Part 1), or with fixed stable dose enzalutamide (for Part 2), with no change in dose for at least 2 weeks prior to screening;
• •7. Serum testosterone level \<50 ng/dL (\<0.5 ng/mL, \<7.0 nmol/L).
• •8. ECOG performance status of 0 or 1;
• •9. Adequate baseline organ function;
• •10. Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) \<470 milliseconds (msec) or \<480 msec with bundle branch block;
• •11. Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;
• •12. Willing and able to comply with all protocol required visits and assessments.