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NCT07057349 · ClinicalTrials.gov registry record · Phase 1
CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer
A Phase 1 study, sponsored by Cytosite Biopharma.
- Not yet
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT07057349 is a Phase 1 study that has not yet begun recruiting, run by Cytosite Biopharma. The registered enrollment target is 40 participants.
The verdict
NCT07057349, a Phase 1 study, has not yet begun recruiting, sponsored by Cytosite Biopharma.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG [18F]CSB-321
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2029-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07057349
The ClinicalTrials.gov registry entry for NCT07057349 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cytosite Biopharma, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [18F]CSB-321 is the first listed.
NCT07057349 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07057349 about?
NCT07057349 is a clinical study titled "CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer". 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 ad...
What is the current status of trial NCT07057349?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-09-01. Estimated completion is 2029-02.
What interventions are being tested in trial NCT07057349?
The interventions under investigation include: [18F]CSB-321 (DRUG).
Who is sponsoring clinical trial NCT07057349?
This trial is sponsored by Cytosite Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
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