JS212 Combination Therapies in Metastatic Colorectal Cancer

Recruiting now · Phase 2

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07503756

Run by

Shanghai Junshi Bioscience Co., Ltd.

People needed

80

Starts

2026-04-25

Expected to finish

2028-03-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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