JS212 Combination Therapies in Metastatic Colorectal Cancer

Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Study ID
NCT07503756
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JS212 — DRUG
    Bispecific antibody-drug conjugate targeting EGFR and HER3
  • Capecitabine — DRUG
    Oral fluoropyrimidine chemotherapy
  • Bevacizumab — DRUG
    Humanized anti-VEGF monoclonal antibody
  • Oxaliplatin — DRUG
    Platinum-based chemotherapy administered intravenously
  • JS207 — DRUG
    Bispecific antibody targeting PD-1 and VEGF

Study Details

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 Dates

First listed
Mar 31, 2026
Start date
Apr 25, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JS212 + Capecitabine
    Participants receive JS212 in combination with Capecitabine.
  • Experimental: JS212 +Capecitabine+ Bevacizumab
    Participants receive JS212 in combination with Capecitabine and Bevacizumab
  • Experimental: JS212 + XELOX
    Participants receive JS212 in combination with XELOX chemotherapy (capecitabine plus oxaliplatin)
  • Experimental: JS212 + XELOX + JS207
    Participants receive JS212 in combination with XELOX chemotherapy and JS207

Primary Outcome Measure

Investigator-assessed objective response rate (ORR) [ Time Frame: Up to approximately 12 months ]

Central Contacts

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