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.
CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ryan Sullivan, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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What this trial measures
- 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.