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JS212 Combination Therapies in Metastatic Colorectal Cancer
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
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 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-04-15
Completion Date
2028-03-30
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
JS212+Capecitabine+Oxaliplatin
Bispecific antibody-drug conjugate targeting EGFR and HER3.Oral fluoropyrimidine chemotherapy.Platinum-based chemotherapy administered intravenously.
JS212+JS207+Capecitabine+Oxaliplatin
Bispecific antibody-drug conjugate targeting EGFR and HER3,Bispecific antibody targeting PD-1 and VEGF,Oral fluoropyrimidine chemotherapy,Platinum-based chemotherapy administered intravenously.
Locations (1)
Shanghai East Hospital
Shanghai, Shanghai Municipality, China