QLS5316

QLS5316 is an investigational bispecific antibody developed by Qilu Pharmaceutical that targets Claudin 18.2 (CLDN18.2) and CD3. CLDN18.2 is a tight junction protein frequently overexpressed in various solid tumors, particularly gastric, gastroesophageal junction, and pancreatic cancers, while maintaining highly restricted expression in normal tissues. By simultaneously binding to CLDN18.2 on tumor cells and the CD3 receptor on T cells, QLS5316 acts as a T-cell engager, facilitating the recruitment and activation of cytotoxic T cells directly to the tumor site to induce tumor cell lysis. The drug is currently being evaluated in a first-in-human, Phase 1 clinical trial to assess its safety, tolerability, pharmacokinetics, and preliminary efficacy as a monotherapy in patients with advanced solid tumors, including colorectal, gastric, and non-small cell lung cancers.