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humanized anti-GD2 antibody · 1 trial · 1 indication
EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.
| Arm | Type | Description |
|---|---|---|
| humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF | EXPERIMENTAL | One cycle consists of treatment with hu3F8 at a dose of 2.4mg/kg/dose for 3 days (day 1, 3, and 5) in the presence of subcutaneous (sc) GM-CSF (day -4 through 5). These 3 doses of hu3F8 and 10 days of GM-CSF constitute a treatment cycle. Cycles are repeated at \~2-4 week intervals between first days of hu3F8, through 5 cycles. A maximum of 5 cycles will be administered on protocol. If elevations of amylase and/or lipase (\>Grade 1) or clinical signs suggestive of pancreatitis (e.g. upper abdominal pain) occurs, naxitamab and GM-CSF doses should be held until improvement of toxicity to ≤Grade 1 if laboratory elevations and/or pancreatitis is possibly related to either naxitamab or GM-CSF. |
| Name | Type | Description |
|---|---|---|
| humanized anti-GD2 antibody | BIOLOGICAL | - |
| GM-CSF | DRUG | - |
Inclusion Criteria: * Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.) * Patients must be in a ≥2nd complete remission as indicated by appro...
Humanized anti-GD2 antibody is used for the treatment of recurrent osteosarcoma. It is a monoclonal antibody being developed by Y-mAbs Therapeutics, Inc. for this oncology indication. The drug is currently in Phase 2 clinical development and is being studied in patients with recurrent osteosarcoma.
Humanized anti-GD2 antibody targets the GD2 antigen, a disialoganglioside expressed on tumor cells. By binding to GD2, the antibody is designed to direct the immune system against cancer cells. This mechanism is being evaluated in the treatment of recurrent osteosarcoma.
Humanized anti-GD2 antibody is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug for recurrent osteosarcoma. Y-mAbs Therapeutics, Inc. is publicly traded under the ticker symbol YMAB.
Humanized anti-GD2 antibody is in Phase 2 clinical development. It is an investigational drug being studied for recurrent osteosarcoma and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting patients.
Humanized anti-GD2 antibody is being studied in one clinical trial, NCT02502786. This Phase 2 trial evaluates the drug in combination with granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of recurrent osteosarcoma. The trial is enrolling 46 participants in the United States.
Yes, humanized anti-GD2 antibody is also known as Hu3F8. The clinical trial NCT02502786 is titled 'Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma,' confirming that Hu3F8 is the same drug.