A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

Open to males ages 18 years and up

• Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC).
• At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET.
• Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer.
• Has progression by the PCWG3 criteria during or after treatment with either abiraterone or enzalutamide
• Male Age ≥ 18 years.
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).

Demonstrate adequate organ function

• Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403.
• Has received cabazitaxel for the treatment of mCRPC.
• Has received previous treatment with a therapeutic targeting PSMA.
• Has an additional active malignancy requiring therapy that may confound the assessment of the study endpoints.
• Has clinically significant cardiovascular disease
• Has a history of untreated brain metastases
• Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before CTT1403 administration.
• Has known positive status for chronic hepatitis B or hepatitis C
• Known or suspected myelodysplastic syndrome.
• Has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.