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A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

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Trial Profile

A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Sep 2026

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At a glance

  • Drugs Dulpatatug (Primary) ; Capecitabine; Oxaliplatin; Pembrolizumab; Trastuzumab
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 31 Aug 2026 According to an Alligator Bioscience media release, The Company intends to use the net proceeds from the Rights Issue thereby providing funding to at least the topline data readout from the ongoing HLX22 Phase 3 trial.
  • 23 Jul 2026 According to an Alligator Bioscience media release, Topline data from this Phase 3 trial is estimated for the second half of 2027, with a potential launch in the second half of 2029 and first royalties expected from around 2030.
  • 08 Jun 2026 According to an Alligator Bioscience media release, the first patients have now been dosed in all regions participating in the global Phase 3 study of HLX22, including China, Japan, Korea, Latin America, Australia, the United States and Europe.

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