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JS212 Combination Therapies in Metastatic Colorectal Cancer

RecruitingPhase 2Ages 18 Years - 75 YearsAllShanghai Junshi Bioscience Co., Ltd.
NCT07503756 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 recom

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📋 Eligibility rules (as published)
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
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What it tests

  • JS212
  • Capecitabine
  • Bevacizumab
  • Oxaliplatin
  • JS207
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Where

1 site
Shanghai East Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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