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

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

Trial Details

NCT ID

NCT07024615

Phase

PHASE1

Sponsor

Astellas Pharma Global Development, Inc.

Status

RECRUITING

Cancer Type

Pancreatic Ductal Adenocarcinoma Pancreatic Cancer

Interventions

ASP2138
Oxaliplatin
Leucovorin
5-FU
Irinotecan
Gemcitabine

Locations (sample)

Boston, Massachusetts, United States|42.35843,-71.05977
New York, New York, United States|40.71427,-74.00597
Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-discip…
Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosi…
Participant has an available pretreatment tumor sample, if clinically appropriate and meets requirements.
Participant is able to undergo surgery and treatment with adjuvant chemotherapy per institutional standard of care.

For full eligibility, visit ClinicalTrials.gov.

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