A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Targeted Technology
• Collaborator: University of California, San Francisco
• Treatments: Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.