Drug intelligence / Profile preview

anbenitamab repodatecan + capecitabine + enlonstobart

Development stage
Phase 2
Lead developer
AlphaMab Oncology
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

**anbenitamab repodatecan + capecitabine + enlonstobart** (also known as JSKN003 + capecitabine + SG001) is an investigational combination regimen being developed by Alphamab Oncology and CSPC Pharmaceutical Group for the treatment of HER2-positive advanced or metastatic solid tumors, particularly gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma. The regimen combines three therapeutic agents with distinct, synergistic mechanisms of action: anbenitamab repodatecan (JSKN003), a biparatopic antibody-drug conjugate (ADC) targeting two non-overlapping epitopes of HER2 (extracellular domains II and IV) conjugated to a topoisomerase I inhibitor payload; capecitabine, an oral fluoropyrimidine carbamate prodrug that is enzymatically converted to 5-fluorouracil (5-FU) to inhibit thymidylate synthase and disrupt DNA synthesis; and enlonstobart (SG001), a fully humanized IgG4 monoclonal antibody targeting the programmed cell death protein 1 (PD-1) immune checkpoint. By combining targeted cytotoxic delivery, systemic chemotherapy, and immune checkpoint inhibition, this regimen aims to enhance anti-tumor efficacy, overcome resistance, and promote T-cell-mediated anti-tumor immune responses. It is currently being evaluated in Phase II clinical trials as a first-line treatment for HER2-positive advanced gastric and GEJ cancers.

Other names
JSKN-003 + capecitabine + SG-001JSKN-003 + capecitabine + SG001JSKN-003 + capecitabine + enlonstobartJSKN003 + Xeloda + SG001JSKN003 + Xeloda + enlonstobartJSKN003 + capecitabine + SG-001JSKN003 + capecitabine + SG001JSKN003 + capecitabine + SYSA1802JSKN003 + capecitabine + enlonstobartanbenitamab repodatecan + Xeloda + SG001anbenitamab repodatecan + Xeloda + enlonstobartanbenitamab repodatecan + capecitabine + SG-001anbenitamab repodatecan + capecitabine + SG001anbenitamab repodatecan + capecitabine + SYSA1802pukang'anni tuodankang + Xeloda + SG001pukang'anni tuodankang + Xeloda + enlonstobartpukang'anni tuodankang + capecitabine + SG-001pukang'anni tuodankang + capecitabine + SG001pukang'anni tuodankang + capecitabine + enlonstobart
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)PDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)PDCD1LG2 (Programmed cell death 1 ligand 2)TS (Thymidylate synthase)

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