NCT07332533

A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer

A Phase II/III Study of KN026 Combined Chemotherapy With or Without Enlonstobart as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer.

Conditions

• HER2-positive Gastric Cancer

Interventions

Type	Name	Description
DRUG	KN026	In accordance with the protocol
DRUG	Capecitabine	Capecitabine is for oral administration.
DRUG	Enlonstobart	Enlonstobart is administered by intravenous infusion.
DRUG	Oxaliplatin	Oxaliplatin is administered by intravenous infusion.
DRUG	Trastuzumab	Trastuzumab is administered by intravenous infusion.
DRUG	Pembolizumab	Pembolizumab is administered by intravenous infusion.
DRUG	Cisplatin	Cisplatin is administered by intravenous infusion.
DRUG	Fluorouracil	Fluorouracil is administered by intravenous infusion.

Timeline

• Start date: 2025-12-30
• Primary completion: 2032-06-30
• Completion: 2032-12-31
• First posted: 2026-01-12
• Last updated: 2026-01-12