Drug intelligence / Profile preview

SHR-A1811 + adebrelimab + capecitabine or fluorouracil

Development stage: Unknown
Lead developer: Hengrui Pharmaceutical
Modality: Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration: Intravenous, Oral

Overview

This combination therapy is a multi-modality regimen being developed for the treatment of HER2-expressing gastric and gastroesophageal junction (GEJ) adenocarcinomas. It consists of three primary components: **SHR-A1811** (trastuzumab rezetecan), a next-generation HER2-targeting antibody-drug conjugate (ADC) featuring a humanized anti-HER2 IgG1 antibody linked to a topoisomerase I inhibitor payload (SHR9265) via a cleavable linker; **adebrelimab** (AiRuiLi), a humanized IgG4 monoclonal antibody that acts as a PD-L1 immune checkpoint inhibitor; and standard chemotherapy consisting of either **capecitabine** (an oral fluoropyrimidine carbamate) or **fluorouracil** (5-FU). The regimen is designed to provide a synergistic effect by combining targeted cytotoxic delivery, immune system disinhibition, and systemic antimetabolite chemotherapy. It is currently being evaluated in Phase 3 clinical trials as a first-line treatment for advanced or metastatic gastric/GEJ cancer.

Brand names: AiRuiLi
Other names: trastuzumab rezetecan + adebrelimab + capecitabinetrastuzumab rezetecan + adebrelimab + fluorouracilSHR-A1811 + adebrelimab + 5-FU

Targets

TOP1 (DNA Topoisomerase I)TS (Thymidylate synthase)CD274 (Programmed cell death protein 1 ligand 1)ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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