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SYS6010 + SG001 + capecitabine or 5-fluorouracil is a combination therapy developed by CSPC Megalith Biopharmaceutical for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC). The regimen consists of SYS6010, an antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR) with a Dxd analogue payload (JS1) and a cleavable tetrapeptide linker; SG001 (enlonstobart), a recombinant humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor; and a fluoropyrimidine-based chemotherapy (either oral capecitabine or intravenous 5-fluorouracil). This multi-modal approach combines targeted cytotoxicity, immune checkpoint blockade, and antimetabolite chemotherapy to improve outcomes in patients with EGFR-expressing squamous cell carcinomas. The combination is currently being evaluated in a Phase 2/3 clinical study.
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