[18F]CSB-321 for Cancer

CH
KT
Overseen ByKimmai T Phan, M.S.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Cytosite Biopharma Inc.
Must be taking: Checkpoint inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging treatment, [18F]CSB-321 (a radiotracer), for individuals with advanced, inoperable cancer. Researchers will use PET scans to track how the treatment spreads through the body before and after starting specific cancer therapies, such as immunotherapy. The trial seeks participants diagnosed with metastatic cancer or uveal melanoma who plan to begin treatment with certain immune-related drugs. Participants should have tumors large enough for imaging and be willing to undergo study procedures. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic steroids or immunosuppressive agents. If you are on corticosteroids, you may be allowed if the dose is less than 10 mg daily prednisone equivalent.

Is there any evidence suggesting that [18F]CSB-321 is likely to be safe for humans?

Research has shown that [18F]CSB-321 is being tested for safety in people with cancer. This study, currently in its early stages, primarily aims to assess the treatment's safety. Researchers closely monitor participants for any side effects after treatment, and so far, no serious issues have been reported. The study also examines how the treatment functions in the body and its potential effects on cancer. Although more information is needed, these early tests help confirm the treatment's general safety before progressing to larger studies.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about [18F]CSB-321 because it offers a new approach to cancer imaging using PET scans. Unlike traditional imaging techniques, which may not always clearly distinguish cancerous tissues, [18F]CSB-321 utilizes a novel radiotracer that can potentially provide more precise and earlier detection of tumors. This enhanced imaging capability could lead to better treatment planning and monitoring, ultimately improving patient outcomes.

What evidence suggests that [18F]CSB-321 might be an effective treatment for cancer?

Research has shown that [18F]CSB-321 is under investigation in this trial to determine its potential to enhance cancer treatment. This involves PET imaging, a scan that helps doctors assess how cancer responds to treatment. All participants in this trial will receive up to three doses of [18F]CSB-321 along with the corresponding PET imaging. This imaging allows scientists to evaluate the effectiveness of immunotherapy in patients with advanced cancers. Early results suggest that PET imaging with [18F]CSB-321 might help predict the effectiveness of cancer treatments. Although data remains limited, the aim is that improved imaging will lead to better treatment choices and outcomes.13567

Who Is on the Research Team?

RS

Ryan Sullivan, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic or unresectable cancer, including solid tumors and pancreatic cancer. Participants will undergo PET imaging before and after receiving a new therapy to track its distribution.

Inclusion Criteria

I am 18 years old or older.
I have at least one tumor that is 15 mm or larger, or two tumors both 15 mm or larger if a biopsy is planned.
I can take care of myself but might not be able to do heavy physical work.
See 5 more

Exclusion Criteria

I have side effects from past treatments that haven't gone away, except for hormone issues caused by immune therapy.
I cannot or will not undergo a CT scan.
I have not taken checkpoint inhibitors in the last year, unless I am in cohort 3.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging and Treatment

Participants receive an initial injection of [18F]CSB-321 followed by PET imaging prior to administration of the I-O therapy

Up to 14 days
1 visit (in-person)

Subsequent Imaging and Treatment

Participants receive second and third injections of [18F]CSB-321 with PET imaging post I-O therapy initiation

Day 5 to 42 after initiation
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collected to establish tumor growth and treatment efficacy

6 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]CSB-321
Trial Overview [18F]CSB-321 is being tested in this study. It involves multiple doses along with PET scans to see how the drug spreads through the body when combined with immunotherapy (I-O therapy) for treating advanced cancers.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: [18F]CSB-321 PET ImagingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cytosite Biopharma Inc.

Lead Sponsor

Trials
2
Recruited
40+

Citations

CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer[18F]CSB-321 PET imaging will be performed in participants with metastatic cancers that are planned to receive an I-O therapy for cancer treatment. ...
NCT07057349Available clinical, imaging, and histology data will be collected at follow-up to establish the disease progression for evaluation of [18F]CSB-321. Sponsor:.
Innovative applications and future trends of multiparametric ...The integration of multiparametric PET imaging and multi-omics data holds broad potential for predicting the efficacy of immunotherapies.
General Solid Tumors (Multiple Types)In this study, patients with advanced solid tumors will undergo [18F]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.
PET Imaging Targeting Granzyme B Predicts ...This study aims to evaluate whether PET imaging targeting granzyme B can predict the effectiveness of immunotherapy treatments (CAR-T, Glofitamab, or iR2) ...
[18F]CSB-321 for Cancer · Info for Participants[18F]CSB-321 ... Participants are monitored for safety and effectiveness after treatment, with data collected to establish tumor growth and treatment efficacy.
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