Actively Recruiting
JS212 Combination Therapies in Metastatic Colorectal Cancer
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2026-05-05
80
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
JS212 Combination Therapies in Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
Y
Ying Zhang, Master
CONTACT
H
Huiyu Lan, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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