NCT06532006

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

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: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Detailed description

In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W). In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.

Conditions

• Gastroesophageal-junction Cancer
• Monoclonal Antibody
• Gastric Cancer
• HER2-positive Gastric Cancer

Interventions

Type	Name	Description
DRUG	HLX22	HLX22 15mg/kg Q3w
DRUG	Pembrolizumab	Pembrolizumab 200mg q3w
DRUG	Trastuzumab	Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
DRUG	Oxaliplatin	Oxaliplatin 130 mg/m2 ,Q3W
DRUG	Capecitabine	Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W

Timeline

• Start date: 2024-11-22
• Primary completion: 2027-06-01
• Completion: 2028-09-01
• First posted: 2024-08-01
• Last updated: 2026-02-27

Locations

208 sites across 17 countries: United States, Argentina, Australia, Brazil, Chile, China, Georgia, Germany, Greece, Italy, Japan, Peru, Poland, Romania, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study