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A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

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Trial Profile

A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 Oct 2024

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At a glance

  • Drugs Iodofalan I-131 (Primary)
  • Indications Glioblastoma
  • Focus Adverse reactions
  • Acronyms IPAX-2
  • Sponsors Telix Pharmaceuticals

    • Most Recent Events

    • 24 Oct 2024 According to a Telix Pharmaceuticals media release, USFDA has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara). The application has been granted priority review and designated a PDUFA goal date of 26 April 2025, paving the way for a U.S. commercial launch in 2025.
    • 03 Sep 2024 According to a Telix Pharmaceuticals media release, data from IPAX-1, IPAX-2 and IPAX-Linz studies, will inform the design of companys future registration-enabling trial for TLX101.
    • 03 Sep 2024 According to a Telix Pharmaceuticals media release, Professor Josef Pichler, Kepler University Hospital, Austria is the Principal Investigator of this trial.

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