A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer
NCT06885385 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-06-24
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
- 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 of 1000mg/m2 will be administered orally twice daily from day 1 to 14 every 21 day cycle
- DRUG
-
Oxaliplatin of 130mg/m2 will be administered intravenously (IV) on day 1 every 21 day cycle
Sponsors & Collaborators
-
Shanghai Junshi Bioscience Co., Ltd.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-23
- Primary Completion
- 2026-11-27
- Completion
- 2027-02-13
Countries
- China
Study Locations
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