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NOT YET RECRUITING
NCT07503756
PHASE2

JS212 Combination Therapies in Metastatic Colorectal Cancer

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

JS212+Capecitabine+Oxaliplatin

Bispecific antibody-drug conjugate targeting EGFR and HER3.Oral fluoropyrimidine chemotherapy.Platinum-based chemotherapy administered intravenously.

DRUG

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