RecruitingPhase 2NCT06885385

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


Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

60 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a combination of two experimental drugs — JS207 and JS015 — together with chemotherapy in people with advanced (stage IV) colorectal cancer that has not been treated with systemic therapy before, and specifically in tumors with a genetic profile called MSS/pMMR (which historically does not respond well to immunotherapy alone). **You may be eligible if...** - You are between 18 and 75 years old - You have stage IV colorectal or rectal adenocarcinoma confirmed by biopsy - Your tumor is MSS or pMMR (a specific genetic type) - You have not had prior systemic treatment for advanced disease (adjuvant therapy more than 12 months ago may be acceptable) - Your cancer is measurable on imaging - You are in good overall health (ECOG 0 or 1) **You may NOT be eligible if...** - You have previously received PD-1/PD-L1 or DKK1 inhibitor therapy - You are pregnant or breastfeeding - You have significant heart, liver, or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALJS207

JS207 will be administered every 3 weeks for a treatment cycle of 21 days

BIOLOGICALJS015

JS015 will be administered every 3 weeks for a treatment cycle of 21 days

DRUGCapecitabine

Capecitabine of 1000mg/m2 will be administered orally twice daily from day 1 to 14 every 21 day cycle

DRUGOxaliplatin

Oxaliplatin of 130mg/m2 will be administered intravenously (IV) on day 1 every 21 day cycle


Locations(2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06885385


Related Trials