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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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Trial Profile

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: 24 Oct 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

  • 23 Jun 2025 According to ITM Isotope Technologies media release, company announced that the first patient was imaged in a new study arm of a five-part (Part D), Phase 1/2 clinical trial evaluating the theranostic pair ITM-94/ITM-91 for identification and treatment of patients who have unresectable, locally advanced or metastatic solid tumors. This study arm is expected to enroll approximately 36 patients at around 15 clinical sites across the EU, US and Australia.
  • 22 Apr 2025 Protocol has been amended as above-Number of arms changed from 3 to 5, where in Experimental: Part D: [68Ga]Ga-DPI-4452 and Experimental: Part E: [68Ga]Ga-DPI-4452 added to study protocol. Primary, secondary outcome measures and inclusion, exclusion criteria along with new indications updated in study protocol. Planned number of patients also increased.
  • 22 Apr 2025 Planned number of patients changed from 170 to 270.

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