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RECRUITING
NCT07024615
PHASE1

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

Sponsor: Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-10-16

Completion Date

2028-01-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

ASP2138

Subcutaneously

DRUG

Oxaliplatin

Injection

DRUG

Leucovorin

Injection

DRUG

5-FU

Injection

DRUG

Irinotecan

Injection

DRUG

Gemcitabine

Intravenously

DRUG

Nab-paclitaxel

Intravenously

DRUG

Capecitabine

Oral

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, United States