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A Confirmatory, Prospective, Global, Multicenter, Phase III Trial of 89Zr-DFO-Girentuximab (TLX250) for the Imaging of Clear Cell Renal Cell Cancer (ccRCC) with Positron Emission Tomography (PET)

Trial Profile

A Confirmatory, Prospective, Global, Multicenter, Phase III Trial of 89Zr-DFO-Girentuximab (TLX250) for the Imaging of Clear Cell Renal Cell Cancer (ccRCC) with Positron Emission Tomography (PET)

Planning
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2018

At a glance

  • Drugs Girentuximab Zr-89 (Primary)
  • Indications Renal cell carcinoma
  • Focus Diagnostic use
  • Acronyms ZIRCON
  • Most Recent Events

    • 23 Aug 2018 According to a Heidelberg Pharma AG media release, under the terms of the agreement with Telix, Heidelberg Pharma is eligible to receive upfront and milestone payments totaling USD 3.7 million. The approval of the CTA to initiate this trial in Europe, will trigger a development milestone payment to Heidelberg Pharma.
    • 23 Aug 2018 According to a Heidelberg Pharma AG media release, this study is planned as a global study with 15 sites in Europe, up to 4 sites in Australia and 6 to 8 sites in the US, subject to regulatory approval in the various jurisdictions.The trial is expected to take 9 to12 months to fully recruit.
    • 23 Aug 2018 According to a Telix Pharmaceuticals media release, company has submitted a Clinical Trial Application (CTA) to initiate this trial in Europe.
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