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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: 18 Aug 2025

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At a glance

  • Drugs HLX 22 (Primary) ; Capecitabine; Oxaliplatin; Pembrolizumab; Trastuzumab
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 14 Jul 2025 According to Henlius Biopharmaceuticals media release, this study is co-led by Prof. Lin Shen from Peking University Cancer Hospital and Professor Jaffer A. Ajani (MD Anderson Cancer Center; Chair of the NCCN Guidelines Panel for Gastric and Esophageal Cancers), and has previously dosed first patients in China, Japan, Australia, and South Korea, with IND approvals obtained in Chile, Brazil, Argentina and other countries and regions.
  • 14 Jul 2025 According to Henlius Biopharmaceuticals media release, first patient with HER2+ GC has been dosed in USA in this trial.
  • 14 Jul 2025 According to a Shanghai Henlius Biotech media release, the first patient has been dosed in this trial in the United States.

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