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Humanized 3F8 Monoclonal Antibody · 1 trial · 1 indication
At least 3 patients will be studied at each dosage level and dose escalations will only be carried out if 0/3 or \< or = to 1/6 patients have dose-limiting toxicity (DLT). At least six patients will be studied at the maximum tolerated dosage (MTD).
| Arm | Type | Description |
|---|---|---|
| Humanized 3F8 Monoclonal Antibody (Hu3F8) | EXPERIMENTAL | This phase I single arm trial assesses the toxicity of escalating doses of hu3F8. |
| Name | Type | Description |
|---|---|---|
| Humanized 3F8 Monoclonal Antibody (Hu3F8) | BIOLOGICAL | Hu3F8 is infused IV over \~30 minutes |
Inclusion Criteria: * Patients must have either (1) a diagnosis of NB as defined by international criteria,56 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels, or (2) a tumor that is GD2-positive by immunostaining with m3F8....
Humanized 3F8 Monoclonal Antibody is an investigational monoclonal antibody being studied for the treatment of neuroblastoma, specifically in patients with high-risk neuroblastoma and GD2-positive tumors. It is currently in Phase 1 clinical development.
Humanized 3F8 Monoclonal Antibody targets GD2, a tumor-associated antigen expressed on neuroblastoma cells. The antibody is designed to bind to GD2-positive tumors, and its development is biomarker-selected for patients whose tumors express this antigen.
Humanized 3F8 Monoclonal Antibody is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol YMAB.
Humanized 3F8 Monoclonal Antibody is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.
Humanized 3F8 Monoclonal Antibody has been studied in one completed clinical trial, NCT01419834, titled 'Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors.' This Phase 1 trial enrolled 68 patients in the United States.
Yes, Humanized 3F8 Monoclonal Antibody is also known as Hu3F8. The clinical trial NCT01419834 uses the name Hu3F8 to refer to the same investigational drug.