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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: 01 May 2025

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At a glance

  • Drugs DEBIO 0228 (Primary) ; Debio 0328 (Primary)
  • Indications Adenocarcinoma; Bladder cancer; Colorectal cancer; Head and neck cancer; Non-small cell lung cancer; Pancreatic ductal carcinoma; Renal cell carcinoma; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms GaLuCi
  • Sponsors Debiopharm

Most Recent Events

  • 22 Apr 2025 Protocol has been amended as above-1) Number of treatment arms has been changed from 3 to 5.2) Planned patient enrollment has been changed from 170 to 270. 3) Indications has been amended.
  • 22 Apr 2025 Planned number of patients changed from 170 to 270.
  • 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.

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