Drug intelligence / Profile preview

JSKN003 + capecitabine + SG001 + oxaliplatin

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

JSKN003 + capecitabine + SG001 + oxaliplatin is an investigational combination regimen under clinical evaluation for the first-line treatment of HER2-positive advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. The regimen combines JSKN003 (anbenitamab repodatecan), a biparatopic HER2-targeting antibody-drug conjugate (ADC) carrying a topoisomerase I inhibitor payload, with SG001 (enlonstobart), a fully humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, and the standard chemotherapy backbone of capecitabine (an oral fluoropyrimidine) and oxaliplatin (a platinum-based alkylating agent). By combining targeted HER2 inhibition, cytotoxic chemotherapy, and immune checkpoint blockade, the regimen aims to achieve synergistic anti-tumor activity. In the Phase II JSKN003-003 trial, this combination (Cohort C) demonstrated preliminary efficacy and safety in treatment-naive patients with HER2-positive gastric/GEJ cancer.

Other names
JSKN003 + capecitabine + SG 001 + oxaliplatinJSKN003 + capecitabine + SG-001 + oxaliplatinJSKN003 + capecitabine + enlonstobart + oxaliplatinJSKN003-003 Cohort CJSKN-003-003 Cohort CJSKN 003-003 Cohort C
02

Targets

CD274 (Programmed cell death protein 1 ligand 1)DNAERBB2 (Erb-b2 receptor tyrosine kinase 2)PDCD1 (Programmed cell death protein 1 receptor)PDCD1LG2 (Programmed cell death 1 ligand 2)TS (Thymidylate synthase)

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