Astellas Launches Phase I/Ib Clinical Trial of CD3/CLDN18.2 Bispecific Antibody ASP2138 in China

On May 30, according to the CDE Clinical Trial Registration and Information Disclosure Platform, Astellas (ALPMY.US) initiated a Phase I/Ib study in China for its CD3/CLDN18.2 bispecific antibody ASP2138. The study aims to evaluate the efficacy and safety in patients with CLDN18.2-expressing metastatic or locally advanced unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma, or metastatic pancreatic adenocarcinoma (Registration Number: CTR20241945).

It is reported that the study was registered and initiated on ClinicalTrials.gov in May 2022 (Registration No.: NCT05365581), planning to enroll 275 participants globally, and completed the enrollment of the first participant in June 2022. The part launched this time is in China.

Data shows that ASP2138 is a bispecific antibody that can bind to CD3 and CLDN18.2. According to the Insight database, Astellas has also developed a bispecific trivalent antibody targeting CLDN6/CLDN-18.2/CD3, which has not yet entered clinical trials.

Editor: Guo Mingyu