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A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone And/or Bone Marrow

Trial Profile

A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone And/or Bone Marrow

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Naxitamab (Primary) ; Sargramostim
  • Indications Neuroblastoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Y-mAbs Therapeutics

Most Recent Events

  • 03 Mar 2025 Primary endpoint has been met. (Response rate during Naxitamab treatment)
  • 03 Mar 2025 According to a Y-mAbs Therapeutics Media Release, company announced the publication of interim data from a Phase 2 clinical trial evaluating naxitamab with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with relapsed/refractory high-risk neuroblastoma in the journal Nature Communications.
  • 03 Mar 2025 Interim results presented in the Y-mAbs Therapeutics Media Release.

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