Phase 11b Study Testing ASP2138 Alone or With Standard Treatments for Advanced Stomach, Gastroesophageal Junction, or Pancreatic Cancer Evaluating Safety, Dosage, and Effects in Adults with CLDN18.2 Positive Tumors

What this Trial Is About

Researchers are investigating ASP2138, a potential treatment targeting the claudin 18.2 CLDN18.2 protein found on cells in the digestive system and some tumors. This study focuses on adults 18 years or older with stomach cancer, gastroesophageal junction GEJ cancer, or pancreatic cancer that is locally advanced unresectable or metastatic and expresses the CLDN18.2 marker. The study aims to understand how ASP2138 is processed by the body and to identify suitable dosing when given alone or combined with standard cancer treatments. The study includes two phases Phase 1 involves giving ASP2138 in escalating doses either intravenously or by subcutaneous injection, alone or with standard treatments such as pembrolizumab and mFOLFOX6, ramucirumab and paclitaxel, or mFOLFIRINOX depending on the cancer type. Phase 1b uses doses determined in Phase 1 to treat participants with these cancers, again either as monotherapy or combined with standard treatments. An end-of-treatment visit occurs 7 days after the final dose or if treatment is stopped early. Participants will have their safety and tolerance to ASP2138 monitored closely through assessments including adverse events, laboratory and vital sign tests, electrocardiograms, and physical exams over several months. Researchers will also measure ASP2138 blood levels, tumor response, and changes in tumor markers. The study follows participants for up to 27 months to gather comprehensive data on treatment effects and safety.

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer