Status:
COMPLETED
A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
Cancer Targeted Technology
Collaborating Sponsors:
University of California, San Francisco
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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).
Detailed Description
This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one androgen signali...
Eligibility Criteria
Inclusion
- 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
- Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403.
- Has received prior systemic anti-cancer therapy (excluding radiopharmaceutical) within 14 days, or 5 half-lives, whichever is shorter, prior to first dose of CTT1403.
- Has received external-beam radiation within 14 days 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 evidence of diffuse bone marrow involvement by prostate cancer in the judgment of study investigator.
- Clinically significant urinary obstruction or moderate/severe hydronephrosis on baseline imaging.
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03822871
Start Date
April 1 2019
End Date
February 8 2023
Last Update
March 21 2024
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 9410794143