Phase 1b2 Study of ASP546C Infusions for Adults With Advanced Gastroesophageal, Pancreatic, or Other Solid Tumors Expressing CLDN18.2

What this Trial Is About

Researchers are evaluating ASP546C in adults with gastroesophageal junction GEJ cancer, gastric cancer, pancreatic cancer, and certain other solid tumors. The study aims to find the most suitable dose of ASP546C, an intravenous drug given by infusion every three weeks. The study includes participants with locally advanced unresectable or metastatic forms of these cancers and focuses on tumors expressing the CLDN18.2 protein. The study has two parts. In Part 1, participants with gastric or GEJ cancer receive either a lower or higher dose of ASP546C through an intravenous infusion every three weeks. Part 2 includes participants with pancreatic cancer or other specific solid tumors excluding gastric or GEJ cancers, all receiving the higher dose of ASP546C on the same schedule. Participants visit the clinic regularly for infusions and health assessments, with the frequency and number of visits depending on individual health status and ongoing treatment. During the study, participants will undergo various health checks including imaging to assess tumor response, blood tests for drug levels and safety monitoring, and evaluations of adverse events and performance status. Researchers will measure outcomes such as tumor response rate, disease control, survival, and drug pharmacokinetics over up to 39 months. Participants safety and wellbeing will be closely monitored throughout the treatment period.

A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors