RecruitingPhase 1NCT07024615

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

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


Sponsor

Astellas Pharma Global Development, Inc.

Enrollment

25 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ASP2138 given before surgery in people with pancreatic cancer whose tumors test positive for a protein called claudin (CLDN) 18.2, followed by standard chemotherapy after surgery. **You may be eligible if...** - You have been diagnosed with pancreatic adenocarcinoma that is localized (not spread) and considered removable by surgery - You have not received any prior treatment for this cancer - Your tumor tests positive for the CLDN18.2 protein - You are healthy enough to undergo surgery and adjuvant chemotherapy - Your heart function is adequate based on clinical assessment **You may NOT be eligible if...** - Your cancer has spread beyond the pancreas or is not surgically removable - You do not have the CLDN18.2 protein in your tumor - You have certain serious heart conditions - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGASP2138

Subcutaneously

DRUGOxaliplatin

Injection

DRUGLeucovorin

Injection

DRUG5-FU

Injection

DRUGIrinotecan

Injection

DRUGGemcitabine

Intravenously

DRUGNab-paclitaxel

Intravenously

DRUGCapecitabine

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

View Full Details on ClinicalTrials.gov

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NCT07024615


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