Phase 1b Study of ASP2138, a CLDN18.2-directed CD3 Activator Bispecific mAb

Adults with resectable pancreatic ductal adenocarcinoma expressing CLDN18.2 receive neoadjuvant subcutaneous ASP2138 followed by investigator-selected adjuvant chemotherapy (mFOLFIRINOX, gemcitabine/nab-paclitaxel, or gemcitabine/capecitabine) to evaluate safety, feasibility, and early signs of efficacy. The study is sponsored by Astellas Pharma Global Development, Inc. For resectable PDAC, perioperative multi-agent chemotherapy (often mFOLFIRINOX) is standard; immunotherapy hasn’t improved outcomes. This trial tests whether pre-op T-cell redirection can deepen pathologic response without delaying surgery.