Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Naxitamab · 3 trials · 5 indications
This measure will be assessed by evaluating treatment side effects.
This measure will be assessed using the 1993 International Neuroblastoma Response Criteria (INRC) criteria.
Measured by the presence of radiologically assessable disease by cross-sectional computed tomography (CT) or Magnetic resonance imaging (MRI) imaging and/or by metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) response for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 International Neuroblastoma Response Criteria (INRC) and compare to relevant historical controls.
The duration of naxitamab infusion that is safe and tolerable will be measured using the endpoint of an occurrence of any dose limiting toxicity. A modified 3+3 design will be used, where the 'modification' permits a single duration level de-escalation in addition to the typical duration group level escalation.
| Arm | Type | Description |
|---|---|---|
| Naxitamab and GM-CSF | EXPERIMENTAL | All enrolled patients receive Naxitamab and GM-CSF in combination with induction therapy for newly-diagnosed high-risk neuroblastoma |
| HRNB Newly diagnosed subjects | EXPERIMENTAL | 5 cycles of standard of care induction + naxitimab Naxitimab on Days 1, 3, and 5 of each cycle |
| Naxitamab Infusion+ Ironotecan + Temozolomide + Sargramostim | EXPERIMENTAL | Participants will be enrolled in a modified 3+3 design to establish a maximum tolerated, infusion duration for Naxitamab. Dosage will start at Duration Level 1 and will de-escalate to Duration Level -1 or escalate to Duration Level 2 according to dose-limiting toxicity (DLT) criteria. * Baseline visit * Cycle 1 (21 day cycle): * Days 1, 3, and 5: Predetermined dose of Naxitamab 1x daily * Days 1 through 5: Predetermined dose of Temozolomide 1x daily * Days 1 through 5: Predetermined dose of Ironotecan 1x daily * Days 6 through 12: predetermined dose of Sargramostim 1x daily * Cycles 2 through 6 (21 day cycles): * Imaging on Cycles 2, 4, and 6 * Days 1, 3, and 5: Predetermined dose of Naxitamab 1x daily * Days 1 through 5: Predetermined dose of Temozolomide 1x daily * Days 1 through 5: Predetermined dose of Ironotecan 1x daily * Days 6 through 12: predetermined dose of Sargramostim 1x daily * End of treatment visit * Follow up at 1 year post-treatment |
| Name | Type | Description |
|---|---|---|
| Naxitamab | DRUG | Naxitamab and GM-CSF administered with COG type induction chemotherapy. |
| Irinotecan | DRUG | Topoisomerase Inhibitor, single-dose vial, via intravenous infusion per standard of care |
| Temozolomide | DRUG | Alkylating agent, capsule, via orally (by mouth) per standard of care |
| Sargramostim granulocyte-macrophage colony stimulating factor | DRUG | Recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF), multi-use vial, via subcutaneously (under the skin) injection per standard of care |
Inclusion Criteria: * Age - 12 months to 21 years at protocol enrollment * Clinical eligibility criteria: 1. Newly diagnosed high risk neuroblastoma. 2. BOTH stage M (INRG - International Neuroblastoma Risk Group) and age ≥547 days. 3. Patients ≥ 547 days of age who were initially diagnosed ...
Naxitamab is an investigational antibody being studied for the treatment of neuroblastoma, including high-risk neuroblastoma. It is being evaluated in patients with newly diagnosed high-risk disease and in those with relapsed or refractory neuroblastoma. The drug is currently in clinical development and has not been approved by the FDA.
Naxitamab is a monoclonal antibody, indicated by its -mab suffix. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential role in treating neuroblastoma, a cancer that primarily affects children.
Naxitamab is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol YMAB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with neuroblastoma.
Naxitamab is in Phase 2 clinical development. It is being studied in multiple ongoing trials, including a Phase 2 trial for newly diagnosed high-risk neuroblastoma and a Phase 1 trial for relapsed or refractory neuroblastoma. The drug remains investigational and is not yet approved.
Naxitamab is being studied in several recruiting trials. NCT05489887 is a Phase 2 trial adding naxitamab to induction therapy for newly diagnosed high-risk neuroblastoma. NCT07027748 is a Phase 1 feasibility study of prolonged naxitamab with irinotecan and temozolomide for relapsed or refractory neuroblastoma. NCT07537400 is a Phase 2 trial in Israel for newly diagnosed high-risk neuroblastoma.
Naxitamab is a distinct investigational antibody being developed specifically for neuroblastoma. It is being tested in combination with other agents such as irinotecan, temozolomide, and GM-CSF in clinical trials. No alternative names for naxitamab have been reported in the trial information.