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A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients With Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)

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Trial Profile

A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients With Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs Sirexatamab (Primary) ; Tislelizumab (Primary) ; Capecitabine; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms DisTinGuish
  • Sponsors Leap Therapeutics

    • Most Recent Events

    • 28 Jan 2025 According to a Leap Therapeutics media release, clinical data from this study will be presented in a conference call hosted by the company January 28, 2025, at 8:00 a.m. ET.
    • 28 Jan 2025 According to a Leap Therapeutics media release, the initial data from part C of this study demonstrates activity in biomarker populations, but did not generate a clear positive signal and will be negative on the primary PFS endpoints upon study completion, resulting in not moving forward with Phase 3 studies in gastric cancer.
    • 28 Jan 2025 Results presented in the Leap Therapeutics Media Release

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