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Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms.

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Trial Profile

Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms.

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 28 Dec 2023

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At a glance

  • Drugs Omburtamab-I-131 (Primary) ; Omburtamab-I-131 (Primary)
  • Indications CNS cancer; Ependymoma; Glioblastoma; Malignant melanoma; Medulloblastoma; Meningeal carcinomatosis; Neuroblastoma; Retinoblastoma; Rhabdoid tumour
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Y-mAbs Therapeutics
  • Most Recent Events

    • 18 Dec 2023 Status changed from active, no longer recruiting to discontinued.
    • 28 Oct 2022 According to a Y-mAbs Therapeutics media release, the U.S. Food and Drug Administration ("FDA") Oncologic Drugs Advisory Committee ("ODAC") voted 16 to 0 that the company had not provided sufficient evidence to conclude that omburtamab improves overall survival.
    • 01 Sep 2022 According to a Y-mAbs Therapeutics media release, the company announced that a meeting of the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration has been scheduled for October 28, 2022 to review the Companys Biological License Application for its product candidate, OMBLASTYS (omburtamab).
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