JS212 combination treatments for metastatic colorectal cancer.
Official title: An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer
Run by Shanghai Junshi Bioscience Co., Ltd. · NCT07503756 · Data updated 2026-11-12
This Phase 2 trial will test whether the experimental drug JS212, given with standard chemotherapy (capecitabine with or without bevacizumab or XELOX) and sometimes the immune drug JS207, is safe and active in adults with metastatic colorectal cancer who have not had prior systemic therapy for advanced disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. Academic / other |
| Drugs / interventions | Bevacizumab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 25, 2026 |
| Main results expected | December 30, 2027 |
| Study ends | March 30, 2028 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07503756 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with histologically confirmed metastatic colorectal adenocarcinoma that is MSS/pMMR, no prior systemic therapy for advanced disease, at least one measurable lesion, and ECOG performance status 0–1.
✕Probably not a fit
Patients with MSI-high/dMMR tumors, prior systemic therapy for metastatic disease, prior exposure to EGFR- or HER3-targeted ADCs, or significant uncontrolled comorbidities are unlikely to be eligible and may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, multicenter Phase 2 trial tests JS212, a bispecific antibody-drug conjugate that targets EGFR and HER3 and delivers a topoisomerase I inhibitor, given in combination with capecitabine ± bevacizumab or with XELOX ± the PD-1/VEGF bispecific JS207. A BOIN dose-escalation phase will identify the maximum tolerated dose and recommended Phase 3 dose, followed by dose-expansion cohorts to further characterize safety, pharmacokinetics, and preliminary antitumor activity. Eligible patients are adults with MSS/pMMR metastatic colorectal adenocarcinoma who are treatment-naïve in the metastatic setting and have measurable disease and ECOG 0–1. Key endpoints include safety and tolerability, pharmacokinetics, and objective tumor responses per RECIST v1.1.
Why it matters
Potential benefit: If successful, these combinations could provide a new first-line option that improves tumor control for patients with MSS metastatic colorectal cancer.
How similar studies have gone: Early clinical data for JS212 and other ADC programs have shown promising safety and antitumor activity, but dual EGFR/HER3 targeting and combinations with PD-1/VEGF bispecifics remain relatively novel and unproven in later-stage trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1Participants must meet the following key criteria * Adults aged 18-75 years with histologically confirmed metastatic colorectal adenocarcinoma * Microsatellite stable (MSS) or mismatch repair proficient (pMMR) disease * No prior systemic therapy for advanced or metastatic disease * At least one measurable lesion according to RECIST v1.1 * ECOG performance status 0-1 * Adequate hematologic, hepatic, renal, and coagulation function * Life expectancy ≥12 weeks * Willingness to provide tumor tissue samples for biomarker analyses * Ability to provide written informed consent Exclusion Criteria: * Participants meeting any of the following criteria will be excluded * Prior treatment with EGFR- or HER3-targeted antibody-drug conjugates or topoisomerase I inhibitor-based ADCs * Recent major surgery, radiotherapy, or systemic anticancer therapy prior to study treatment * Active or uncontrolled infections or significant cardiovascular disease * Known active central nervous system metastases * History of autoimmune disease requiring systemic therapy * Significant bleeding disorders or high risk of hemorrhage * Active viral infections such as uncontrolled hepatitis B, hepatitis C, or HIV * Any other serious medical or psychiatric condition that may interfere with study participation
Where it's running
-
Shanghai East Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Ying Zhang, Master
- Email: ying_zhang2@junshipharma.com
- Phone: 86 18616904609
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.