drugset / Trial / NCT07024615

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

NCT07024615

Phase 1 Recruiting 25 enrolled Astellas Pharma Global Development, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery. In this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine. People will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.

Timeline

Start
2025-10-16
Primary completion
2028-01-31
Completion
2028-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP2138 Unknown Subcutaneous
Background Capecitabine Small molecule Oral
Background Gemcitabine Small molecule Intravenous
Background Irinotecan Small molecule
Background Leucovorin Small molecule
Background Oxaliplatin Small molecule
Background Paclitaxel Small molecule Intravenous
Background fluorouracil Small molecule