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
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.
• 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