JS212 Combination Therapies in Metastatic Colorectal Cancer
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
Shanghai Junshi Bioscience Co., Ltd.
80 participants
Apr 25, 2026
INTERVENTIONAL
Conditions
Summary
This is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC). JS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3 with a topoisomerase I inhibitor payload. Preclinical and early clinical data suggest that dual targeting of EGFR and HER3 may enhance antitumor activity and overcome resistance mechanisms associated with EGFR- or HER2-directed therapies. This study will investigate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (XELOX: capecitabine and oxaliplatin), with or without the PD-1/VEGF bispecific antibody JS207, in patients with mCRC. The study will assess safety, determine the recommended Phase 3 dose (RP3D), and evaluate preliminary antitumor activity of the combination regimens.
Eligibility
Inclusion Criteria10
- Participants 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 Criteria9
- 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
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Interventions
Bispecific antibody-drug conjugate targeting EGFR and HER3
Oral fluoropyrimidine chemotherapy
Humanized anti-VEGF monoclonal antibody
Platinum-based chemotherapy administered intravenously
Bispecific antibody targeting PD-1 and VEGF
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07503756