Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01419834 | Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors | PHASE1 | COMPLETED | 68 | — | — | Aug 15, 2011 | Aug 2, 2023 | Aug 4, 2023 | 1 | United States |
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....