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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

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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: 11 Dec 2023

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At a glance

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

    • Most Recent Events

    • 21 Sep 2023 According to Y-mAbs Therapeutics Inc. media release, data from this study will be Presented at the 55th Congress of the International Society of Pediatric Oncology
    • 06 Jun 2023 Results assessing the reduction in Curie score by baseline disease status, refractory or relapsed, from Trial 201 pre-specified interim analysis (data cut-off 31-dec-2021), presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
    • 26 May 2023 According to a Y-mAbs Therapeutics Media Release, Interim data from this study will be presented at the American Society of Clinical Oncology Annual Meeting to be held June 2-6, 2023, in Chicago, Illinois.
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