CSB-321 Imaging for Metastatic or Unresectable Cancer

This study is testing a new imaging agent called [18F]CSB-321. This agent helps doctors see how your body responds to immunotherapy (treatments that use your immune system to fight cancer). Researchers want to see if [18F]CSB-321 can accurately show how well these treatments are working in people with metastatic (cancer that has spread) or unresectable (cancer that cannot be removed by surgery) solid tumors. You may be eligible if you are 18 or older and have metastatic cancer that will be treated with certain immunotherapies, such as PD-1, PD-L1, CTLA-4, or LAG-3 inhibitors. The study will look at how safe [18F]CSB-321 is and if its uptake in the body matches how your tumor responds to treatment. The study plans to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is an open-label (everyone knows what treatment is being given), non-randomized (participants are not assigned to groups by chance) study that plans to enroll 40 participants.
What's involved
You would receive an initial injection of [18F]CSB-321 followed by PET imaging before starting your immunotherapy, and then two more injections with PET imaging after treatment. You will be monitored for side effects for up to 3-4 hours after each injection.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events for up to 3-4 hours post injection. Available clinical, imaging, and histology data will be collected at follow-up to establish disease progression.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07057349

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Cytosite Biopharma Inc.
~40 participants
Updated 2025-07-09 on ClinicalTrials.gov
What's tested:[18F]CSB-321

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of clinically significant changes
Measured over 3-4 hours post injection
+1 more outcome measured
Metastatic Cancer
Unresectable Solid Tumor
1 sites across 1 states
Massachusetts1
  • Ryan Sullivan, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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  • The number of clinically significant changes3-4 hours post injection

    Clinically significant changes from baseline through follow up analysis in physical examination findings, vital signs, and blood chemistry and AEs.

  • Frequency and grade of adverse events due to [18F]CSB-3213-4 hours post injection

    Number of AE's as assessed by CTCAE 5.0.