NCT06885385

A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer

An Open-label, Multicenter, Phase 2 Clinical Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy (XELOX) as First-line (1L) Treatment in Patients With MSS/pMMR Advanced Colorectal Cance

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open label, multicenter Phase II clinical trial aimed at evaluating the safety and efficacy of JS207 with or without JS015 in combination with chemotherapy (XELOX) as a first-line treatment for advanced colorectal cancer with MSS/pMMR. The study was divided into two cohorts: Cohort 1 was JS207 combined with XELOX, and Cohort 2 was JS207 combined with JS015 and XELOX.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	JS207	JS207 will be administered every 3 weeks for a treatment cycle of 21 days
BIOLOGICAL	JS015	JS015 will be administered every 3 weeks for a treatment cycle of 21 days
DRUG	Capecitabine	Capecitabine of 1000mg/m2 will be administered orally twice daily from day 1 to 14 every 21 day cycle
DRUG	Oxaliplatin	Oxaliplatin of 130mg/m2 will be administered intravenously (IV) on day 1 every 21 day cycle

Timeline

• Start date: 2025-04-23
• Primary completion: 2026-11-27
• Completion: 2027-02-13
• First posted: 2025-03-20
• Last updated: 2025-06-24

Locations

2 sites across 1 country: China