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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: 28 Apr 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

  • 20 Mar 2025 According to an Alligator Biosciences media release, company announced that FDA has granted Orphan Drug Designation for HLX22/AC101 in Gastric Cancer.
  • 20 Mar 2025 According to Alligator Bioscience media release, the study is enrolling patients across the U.S., China, Japan, and Australia
  • 05 Mar 2025 According to Shanghai Henlius Biotech media release, the company held a First In-Person Investigator Meeting in Japan, has further clarified the patient population characteristics, diagnostic and treatment standards, as well as clinical trial protocol in Japan, laying a solid foundation for the efficient advancement of the study.

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