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A Multi-centre, Open-label, Single-arm, Dose-finding Phase I/II Study to Evaluate Safety, Tolerability, Dosing Schedule, and Preliminary Efficacy of Carrier-added 4-L-[131I]Iodo-phenylalanine (131I-IPA), Administered as Single or Repetitive Injections in Patients With Recurrent Glioblastoma Multiforme (GBM), Concomitantly to 2nd Line External Radiation Therapy (XRT) - IPAX- 1

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Trial Profile

A Multi-centre, Open-label, Single-arm, Dose-finding Phase I/II Study to Evaluate Safety, Tolerability, Dosing Schedule, and Preliminary Efficacy of Carrier-added 4-L-[131I]Iodo-phenylalanine (131I-IPA), Administered as Single or Repetitive Injections in Patients With Recurrent Glioblastoma Multiforme (GBM), Concomitantly to 2nd Line External Radiation Therapy (XRT) - IPAX- 1

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 06 Sep 2024

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At a glance

  • Drugs Iodofalan I-131 (Primary)
  • Indications Glioblastoma
  • Focus Adverse reactions
  • Acronyms 131I-IPA + XRT in recurrent GBM; IPAX-1
  • Sponsors Telix Pharmaceuticals

Most Recent Events

  • 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 Results presented in a Telix Pharmaceuticals media release.
  • 03 Sep 2024 According to a Telix Pharmaceuticals media release, clinical data from IPAX-1 Phase I study has been published in Neuro-Oncology Advances, confirming the safety and tolerability profile, and early efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma (GBM), the most common and aggressive form of primary brain cancer.

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