Astellas Launches Phase 3 Trial for Gastric Cancer Drug ASP2138

The study evaluates the efficacy and safety of administering ASP2138 subcutaneously alongside chemotherapy and pembrolizumab. With 570 participants targeted across multiple countries, the trial aims to improve outcomes for patients facing aggressive cancers where standard treatments currently yield a median progression-free survival of only six to seven months. The study, registered under NCT07673887, focuses on co-primary endpoints of overall survival and progression-free survival.

ASP2138 functions by bridging CLDN18.2-expressing tumor cells with CD3-positive T cells, triggering a targeted immune response. Tadaaki Taniguchi, Chief Research and Development Officer at Astellas, noted that this milestone is central to the company’s broader strategy to expand its immuno-oncology portfolio. This trial is part of an ambitious corporate initiative to initiate at least five pivotal or Phase 3 studies by fiscal year 2027.