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.
Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-disciplinary review. Participant with localized pancreatic adenocarcinoma cannot have received any prior therapy.
Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosing may be allowed after discussion with the medical monitor, if results are pending or a biopsy for CLDN18.2 testing is not clinically appropriate). Site should contact the sponsor to assess potential eligibility based on a local test result.
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.
Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.
Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.
Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.
Participant has uncontrolled serious psychiatric illness or social situations that would preclude study compliance.
Single group
ASP2138
DrugSubcutaneously
Oxaliplatin
DrugInjection
Leucovorin
DrugInjection
5-FU
DrugInjection
Irinotecan
DrugInjection
Gemcitabine
DrugIntravenously
Nab-paclitaxel
DrugIntravenously
Capecitabine
DrugOral
Number of participants with Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Number of participants with Serious Adverse Events (SAEs)
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations.
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital signs abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Pharmacokinetics (PK) of ASP2138 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the pharmacokinetic (PK) serum samples collected.
Number of participants at each grade of Pathologic Response
The College of American Pathologists (CAP) grading will be used to assess pathological response. Grades range from 0: No viable cancer cells (complete response) to grade 3: Extensive residual cancer with no evident tumor regression (poor or no response)
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the time from date of surgical resection of pancreas tumor until the date of radiological disease recurrence or death due to any cause
Number of participants with microscopically margin-negative (R0) resection
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