Drug intelligence / Profile preview

SYS6010 + SG001 + capecitabine or 5-fluorouracil

Development stage
Unknown
Lead developer
CSPC Megalith Biopharmaceutical
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Oral
01

Overview

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.

Other names
Enlonstobart5-fluorouracil5-FUCapecitabine
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)DNAPDCD1 (Programmed cell death protein 1 receptor)TS (Thymidylate synthase)

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