Drug intelligence / Profile preview

SHR-A1811 + SHR-1316 + SHR-8068

Development stage
Unknown
Lead developer
Hengrui Pharmaceutical
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

**SHR-A1811 + SHR-1316 + SHR-8068** is an experimental combination therapy being studied for the treatment of HER2-positive, advanced or metastatic biliary tract cancer. SHR-A1811 is a third-generation antibody-drug conjugate (ADC) targeting HER2, comprised of a trastuzumab biosimilar (anti-HER2 antibody) linked to a topoisomerase I inhibitor via a cleavable linker, developed for antitumor activity in HER2-expressing tumors. SHR-1316 is a humanized monoclonal antibody against PD-L1 (programmed death ligand-1), designed to block immune checkpoint signaling and enhance anti-tumor immune response. SHR-8068 is a humanized monoclonal antibody targeting CTLA-4 (cytotoxic T-lymphocyte antigen 4), acting as a checkpoint inhibitor to activate the immune system against tumor cells. This triple regimen is being evaluated in a phase II open-label, multicenter clinical trial in HER2-positive locally advanced or metastatic biliary tract cancer, with all agents administered intravenously[4][6][7].

02

Targets

CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)CD274 (Programmed cell death protein 1 ligand 1)ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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