Phase 1b Study of ASP2138 Injection Before Surgery and Chemotherapy After Surgery in Adults With Resectable Pancreatic Ductal Adenocarcinoma Expressing Claudin 18.2

What this Trial Is About

This research investigates treatments for adults with resectable pancreatic ductal adenocarcinoma PDAC whose tumors express the protein Claudin 18.2 CLDN18.2. The study evaluates the investigational drug ASP2138, which is designed to bind to CLDN18.2 and activate the immune system by engaging T-cells to attack the tumor. The study focuses on people whose tumors can be surgically removed and aims to assess ASP2138 in combination with standard chemotherapy treatments after surgery. Participants will receive an injection of ASP2138 just under the skin two weeks before surgery to remove the tumor. After surgery, participants will undergo standard chemotherapy chosen by their doctor, which may include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine. Chemotherapy treatment will continue for up to six months unless the cancer worsens, the treatment is not tolerated, or the participant or doctor decides to stop. During the study, participants will be monitored for side effects and health through clinic visits, laboratory tests, vital sign checks, physical exams, ECGs, and performance status assessments. A final clinic visit will occur about one month after finishing chemotherapy for health checks. The study will track safety, chemotherapy effects, and surgical outcomes over approximately 11.5 months.

A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer