Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Humanized 3F8 Monoclonal Antibody (Hu3F8)
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 being studied for the treatment of high-risk neuroblastoma and GD2-positive tumors. It is an investigational therapy developed by Y-mAbs Therapeutics, Inc. and has been evaluated in a Phase 1 clinical trial in patients with these conditions.
Humanized 3F8 Monoclonal Antibody is being developed by Y-mAbs Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol YMAB. The company is focused on the development of antibody-based therapeutics for cancer.
Humanized 3F8 Monoclonal Antibody is in Phase 1 clinical development. It has completed one Phase 1 trial but is not yet approved by the FDA. It remains an investigational agent for neuroblastoma and GD2-positive tumors.
Humanized 3F8 Monoclonal Antibody has been evaluated in a completed Phase 1 trial, NCT01419834, titled "Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors." The trial enrolled 68 patients in the United States.
Yes, Humanized 3F8 Monoclonal Antibody is also known as Hu3F8. Both names refer to the same investigational monoclonal antibody developed by Y-mAbs Therapeutics for neuroblastoma and GD2-positive tumors.