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A Multicenter, Open-Label, Non-Randomized Phase 1/2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors

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A Multicenter, Open-Label, Non-Randomized Phase 1/2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 Dec 2024

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At a glance

  • Drugs DEBIO 0228 (Primary) ; Debio 0328 (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Pancreatic ductal carcinoma; Renal cell carcinoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms GaLuCi
  • Sponsors Debiopharm

    • Most Recent Events

    • 12 Sep 2024 According to ITM Isotope Technologies media release, company announced that the companies entered an agreement under which ITM gains the exclusive global license for the clinical and commercial development of the peptide-based, theranostic pair ITM-91/ITM-94D, formerly Debio 0228/0328, targeting the Carbonic Anhydrase IX (CA IX) surface protein.
    • 18 Jul 2024 Planned number of patients changed from 147 to 170.
    • 18 Jul 2024 Planned End Date changed from 1 Jan 2027 to 1 Mar 2029.

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