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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: Clinical Trial Phase 1 study, sponsored by Cytosite Biopharma.
NCT07057349 is a Phase 1 study that has not yet begun recruiting, run by Cytosite Biopharma. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinically significant changes from baseline through follow up analysis in physical examination findings, vital signs, and blood chemistry and AEs.
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 |
What is known before NCT07057349 opens enrollment
NCT07057349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]CSB-321 is the first listed.
NCT07057349 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07057349's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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