Clinical Trial

CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer. Eligible participants will receive an initial injection of \[18F\]CSB-321 followed by PET imaging prior to administration of the I-O therapy and a second and third injection post treatment each with PET imaging. The images will be analyzed for the distribution of radioactivity. Participants will be followed for adverse events up to 3-4 hours post injection. Available clinical, imaging, and histology data will be collected at follow-up to establish the disease progression for evaluation of \[18F\]CSB-321.
Trial Details
NCT Number NCT07057349
Lead Sponsor Cytosite Biopharma Inc.
Conditions Metastatic Cancer, Unresectable Solid Tumor
Enrollment 40 participants
Start Date 2025-09-01
Primary Completion 2027-09 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2025-07-09