JS212 Combination Therapies in 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.

NCT Number	NCT07503756
Lead Sponsor	Shanghai Junshi Bioscience Co., Ltd.
Conditions	Metastatic Colorectal Cancer
Enrollment	80 participants
Start Date	2026-04-25
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-05