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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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Shanghai Henlius Biotech (industry)

Phase: 3

Start date: Nov. 22, 2024

Planned enrollment: 550

Trial ID: NCT06532006
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More trial details at ClinicalTrials.gov More info

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Goal: Determine whether adding HLX22 to first-line trastuzumab and XELOX improves outcomes in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Patients: Adults with previously untreated, unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma, measurable disease, and ECOG performance status 0–1. Patients with prior HER2-targeted therapy, CNS metastases, active gastrointestinal bleeding, or LVEF below 55% are excluded.

Design: Multicenter, double-blind phase 3 trial with 1:1 randomization. Treatment continues until loss of clinical benefit, death, unacceptable toxicity, consent withdrawal, or another protocol-defined reason.

Treatments: The experimental arm receives HLX22 15 mg/kg with trastuzumab and XELOX every 3 weeks, with or without placebo for pembrolizumab. The control arm receives placebo for HLX22 with trastuzumab and XELOX every 3 weeks, with or without pembrolizumab. HLX22 is an investigational anti-HER2 antibody that binds a site distinct from trastuzumab’s; preclinical work suggests the combination increases HER2 receptor internalization and reduces growth signaling. In a smaller randomized phase 2 study, median progression-free survival was not reached with HLX22 versus 8.3 months with placebo, but phase 3 benefit remains unconfirmed.

Outcomes: Primary endpoints are independent radiology-reviewed progression-free survival by RECIST 1.1 and overall survival. Secondary endpoints include investigator-assessed progression-free survival, objective response rate assessed by independent review and investigators, and adverse events. Follow-up for these outcomes is up to 5 years.

Burden on patient: Moderate: treatment requires visits every 3 weeks for antibody therapy and oxaliplatin, alongside oral capecitabine, plus periodic imaging and safety assessments. These visits largely resemble first-line combination-treatment care, but study monitoring may add appointments or tests; the supplied information does not specify mandatory research biopsies or intensive pharmacokinetic sampling.

Last updated: Sep 2026

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