NCT07384377

JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan

A Phase III Trial to Evaluate the Efficacy and Safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the efficacy and safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan subjects.

Conditions

• HER2-positive Colorectal Cancer

Interventions

Type	Name	Description
DRUG	JSKN003	JSKN003 (6.3 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W).
DRUG	Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.	TAS-102(35 mg/m2, maximum 80 mg per dose), twice daily (BID), once every 4 weeks (Q4W); or Regorafenib 160mg, once daily (QD), once every 4 weeks (Q4W); or Fruquintinib 5mg once daily (QD), once every 4 weeks (Q4W).

Timeline

• Start date: 2026-02-06
• Primary completion: 2027-11-30
• Completion: 2028-06-15
• First posted: 2026-02-03
• Last updated: 2026-02-03