Hu3F8 PET Imaging for Brain Cancer

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Major organ dysfunction, Infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying how a special protein called Hu3F8 moves through the body and targets tumors. Hu3F8 is designed to attach to tumor cells, helping the immune system recognize and destroy them. The study focuses on patients with tumors to see how well this protein works in attacking cancer cells.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Hu3F8 PET Imaging for Brain Cancer safe for humans?

In a study with 12 patients who received a similar treatment (Iodine-131 3F8), no side effects were reported, suggesting it may be generally safe in humans. ^{1 2 3 4 5}

How does Hu3F8 PET Imaging for Brain Cancer differ from other treatments?

Hu3F8 PET Imaging is unique because it uses a monoclonal antibody to target GD2-bearing tumors in the brain, allowing for precise imaging of tumor locations without affecting normal brain tissue. This approach is different from standard treatments as it provides a non-invasive method to visualize tumors, potentially improving diagnosis and treatment planning. ^{2 6 7 8 9}

Research Team

Shakeel Modak, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for people aged 3-90 with certain types of cancer (like neuroblastoma, melanoma, sarcoma) that have come back or spread and show GD2 on their cells. They must be able to follow the study plan and women who can have babies need to use birth control. People can't join if they're allergic to iodide/Lugols, had bad reactions to similar drugs before, are pregnant/breastfeeding, or too sick in other ways.

Inclusion Criteria

My cancer has returned or spread and is not responding to treatment.

I have been treated with anti-GD2 antibody, and my antibody levels are low.

I am willing to use effective birth control during the study.

Exclusion Criteria

Positive human anti-hu3F8 antibody titer.

I need sedation to undergo PET/CT scans.

I do not have a severe, life-threatening infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 124I-hu3F8 and undergo PET/CT scans to analyze biodistribution and dosimetry

1 week

Multiple visits for PET/CT scans and blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 124I-Humanized 3F8

Trial Overview The trial is testing a lab-made antibody called Hu3F8 tagged with radioactive iodine (124I). It's designed to see how this antibody moves in the body and targets tumors that have a specific substance on their surface.

Participant Groups

Group I: PET Imaging using 124I-Humanized 3F8 Experimental Treatment 1 Intervention

124I-hu3F8 at a dose of 3mCi/m2 (with a maximum dose of 5mCi) will be injected IV. 124I-hu3F8 PET/CT scans will be performed at approximately 2-4 hours, 18-26hours, 48-72 hours and 96-144 hours after injection of 124I-hu3F8. A low dose CT scan will be obtained with each PET scans. PET/CT scan images will be analyzed to determine biodistribution of 124I-hu3F8 and to determine dosimetry to organs and sites of disease. Comparison of tumor targeting and tumor dosimetry will be made between the two cohorts of patients: (a) NB and (b) other solid tumors. Blood will be drawn where feasible at multiple time points: approximately 0h, 0.5h, 1h, 2h, 4-8h, 24h, 48h, 96h and 120h-144h after injection of 124I-hu3F8 and radioactivity measured to determine pharmacokinetics of 124I-hu3F8.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Y-mAbs Therapeutics

Industry Sponsor

Trials

26

Recruited

1,600+

Findings from Research

The study of 124I-labeled toripalimab (124I-JS001) in 11 patients with melanoma and urologic cancer showed it to be a safe PET imaging tracer with no adverse events and acceptable dosimetry of 0.236 mSv/MBq.

124I-JS001 demonstrated favorable biodistribution, with high uptake in the spleen and liver, and significantly improved tumor detection when combined with unlabeled JS001, indicating its potential as a tool for identifying patients who may benefit from PD-1 therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron Emission Tomography Imaging of Programmed Death 1 Expression in Cancer Patients Using 124I-Labeled Toripalimab: A Pilot Clinical Translation Study. Wang, S., Zhu, H., Ding, J., et al.[2023]

Iodine-131 3F8, a monoclonal antibody targeting GD2-bearing tumors, was safely administered to 12 patients with brain tumors, showing effective localization in 9 out of 11 malignant gliomas and one metastatic melanoma without any side effects.

The best tumor delineation was observed with a 10 mCi dose, and the pharmacokinetics were consistent across different doses, indicating that this antibody can effectively target brain tumors with a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative studies of monoclonal antibody targeting to disialoganglioside GD2 in human brain tumors. Arbit, E., Cheung, NK., Yeh, SD., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Positron Emission Tomography Imaging of Programmed Death 1 Expression in Cancer Patients Using 124I-Labeled Toripalimab: A Pilot Clinical Translation Study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Quantitative studies of monoclonal antibody targeting to disialoganglioside GD2 in human brain tumors. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Iodine-124 as a label for pharmacological PET imaging. [2015]

4. England pubmed.ncbi.nlm.nih.gov

The potential of theragnostic ¹²⁴I-8H9 convection-enhanced delivery in diffuse intrinsic pontine glioma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Quantitative imaging of I-124 using positron emission tomography with applications to radioimmunodiagnosis and radioimmunotherapy. [2017]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of TSPO Receptor Polymorphism on [18F]GE-180 Binding in Healthy Brain and Pseudo-Reference Regions of Neurooncological and Neurodegenerative Disorders. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Radiosynthesis and biological evaluation of [18F]AG-120 for PET imaging of the mutant isocitrate dehydrogenase 1 in glioma. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Assessment of cancer-associated biomarkers by positron emission tomography: advances and challenges. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Determination and reduction of translocator protein (TSPO) ligand rs6971 discrimination. [2020]