NCT06998771

JSKN003 Combined Treatment of HER2-positive Gastric Cancer

A Phase II Trial to Evaluate the Safety and Efficacy of JSKN003 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer or Resectable Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.

Conditions

• HER2-positive Gastric Cancer

Interventions

Type	Name	Description
DRUG	JSKN003	JSKN003 is administered by intravenous infusion.
DRUG	KN026	KN026 is administered by intravenous infusion.
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.

Timeline

• Start date: 2025-06-15
• Primary completion: 2028-06-30
• Completion: 2029-12-31
• First posted: 2025-05-31
• Last updated: 2025-05-31