drugset
drugset / Trial / NCT03363373

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

NCT03363373 ↗

Phase 2 Active not recruiting 122 enrolled Y-mAbs Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Timeline

Start
2018-04-03
Primary completion
2026-06
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Naxitamab Monoclonal antibody 3 mg/kg —
Background sargramostim Protein / enzyme biologic 500 ug/m2 —

Indications

neuroblastoma