Actively Recruiting
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-03-13
25
Participants Needed
3
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed localized pancreatic adenocarcinoma that is upfront resectable
- No prior therapy for localized pancreatic adenocarcinoma
- Positive claudin (CLDN)18.2 test result before first dose of ASP2138
- Available pretreatment tumor sample if clinically appropriate
- Able to undergo surgery and adjuvant chemotherapy per standard of care
- Cardiac function assessed as class 2B or better if history or symptoms of cardiac disease
- Female participants not pregnant and either not of childbearing potential or agree to contraception and not breastfeeding
- Male participants agree to use contraception or abstinence and not donate sperm during and after treatment
- At least one measurable lesion per RECIST v1.1 within 28 days before first dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Corrected QT interval by Fridericia (QTcF) 470 msec or less
- Adequate organ and marrow function based on lab tests within 7 days before first dose
- Agree not to participate in another interventional study during this study
You will not qualify if you...
- Unstable angina, myocardial infarction, ventricular arrhythmia needing intervention, or hospitalization for heart failure within 6 months before first dose
- Active infection requiring systemic therapy not resolved within 7 days before start
- Active autoimmune disease needing immunosuppressive treatment within 1 month before start
- Uncontrolled serious psychiatric illness or social issues preventing compliance
- Another malignancy requiring treatment
- History or complication of interstitial lung disease
- Complete or partial gastric outlet syndrome with persistent vomiting
- Known dihydropyrimidine dehydrogenase (DPD) deficiency if receiving fluoropyrimidine chemotherapy
- Known uncontrolled coagulopathy; full dose warfarin not allowed
- History of bleeding diathesis or recent major bleeding events
- Uncontrolled illness or infection
- Known HIV infection unless CD4+ T cell count 350 cells/µL or higher and no AIDS defining infections in past 6 months
- Active hepatitis B or C infection unless treated and undetectable viral load
- Known UGT1A1 gene polymorphism causing loss of function if receiving irinotecan chemotherapy
- Severe gastric conditions like active gastritis or ulcers
- Prior chemotherapy, radiation, immunotherapy, biologic, or investigational therapy for pancreatic tumor
- Live vaccine within 30 days before planned study start (seasonal flu vaccine allowed)
- Any condition that may affect safe treatment delivery or suitability
- Prior severe allergic reaction or intolerance to study interventions
- Major surgery within 28 days before study start without full recovery
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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