Phase 1 Multi-cohort Evaluation of [18F]CSB-321 PET Imaging in Participants Receiving Immunotherapy for the Treatment of Cancer
Cytosite Biopharma Inc.
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.
Description
This single site, open label, non-randomized, multiple dose phase 1 study, in participants with metastatic cancer which can be treated with checkpoint inhibitor therapy or bi-specific immunological therapy. The primary safety objective is to test the safety of \[18F\]CSB-321 in participants with cancer. The primary efficacy and secondary objectives are to gain evidence in support of the hypothesis that \[18F\]CSB-321 uptake will correlate with tumoral response to treatment with the I-O therapy. \[18F\]CSB-321 PET imaging will be performed in participants with metastatic cancers that are planne…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants 18 years of age and older. 2. Participants with either proven metastatic cancer that are going to be treated with one or more checkpoint inhibitors or immunotherapy under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors OR Participants with unresectable or metastatic uveal melanoma planned to be treated with tebentafusp-tebn 3. Participants must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned from one of the lesion…
Interventions
- Drug[18F]CSB-321
\[18F\]CSB-321 is a PET imaging agent that is bound to released granzyme B from T-cells
Location
- Massachusetts General HospitalBoston, Massachusetts