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A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

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Trial Profile

A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Oct 2025

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At a glance

  • Drugs Fluorine-18 FAPI 74 (Primary)
  • Indications Cholangiocarcinoma; Colorectal cancer; Gastric cancer; Gastrointestinal cancer; Liver cancer; Pancreatic cancer
  • Focus Diagnostic use
  • Acronyms 18F-FAPI-74 GI
  • Sponsors SOFIE

Most Recent Events

  • 01 Oct 2025 Primary endpoint (Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.) has been met, according to a SOFIE Biosciences media release.
  • 01 Oct 2025 Results presented in a SOFIE Biosciences media release.
  • 01 Oct 2025 According to a SOFIE Biosciences media release, company announced the successful completion of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting plans for both of its Phase 3 studies design and endpoints for [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP).

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