Qilu Pharma Initiates Global First Phase III Trial of CLDN18.2/CD3 Bispecific T-cell Engager QLS31905

Jul 23, 2025 19:50 CST Updated 19:50

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

On July 22, the global clinical trial registration website showed that Qilu Pharmaceutical Co., Ltd. initiated the first Phase III clinical trial of QLS31905.

QLS31905 isQilu Pharmaceutical Co., Ltd. has independently developed a bispecific T-cell engager that simultaneously targets Claudin18.2 (CLDN18.2) and CD3, capable of binding toCLDN18.2Binding to CD3 on the surface of T cells, it continuously kills and lyses tumor cells by recruiting and activating T cells near the tumor cells.

This study is a multicenter, randomized, double-blind, controlled Phase III clinical trial (n=602), designed to evaluateQLS31905 Combined with Chemotherapy (Nab-Paclitaxel + Gemcitabine) vs. Placebo Combined with ChemotherapyFirst-line Treatment for CLDN18.2-positive Advanced Pancreatic CancerEfficacy and safety in adult patients. The primary endpoint of the study is progression-free survival (PFS) at 48 months of treatment.

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