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New treatment option for Pancreatic Ductal Adenocarcinoma
Official title A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
ClinicalTrials.gov ID: NCT07024615
What this study is testing
What is ASP2138?
ASP2138 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional...
- Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosing...
- 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 with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk...
You likely can't join if
- Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction...
- 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...
- Participant has uncontrolled serious psychiatric illness or social situations that would preclude study compliance.
- Participant has another malignancy for which treatment is required.
- Participant has a history or complication of interstitial lung disease.
See the full eligibility criteria
Who can join
- Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-disciplinary review. Participant with localized pancreatic adenocarcinoma...
- 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...
- 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 with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function of class 2B or better using the New...
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final ASP2138 intervention administration (or...
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (6 months) after final ASP2138 intervention administration (or follow the...
- Female participant must not donate ova starting at first administration of neoadjuvant ASP2138, throughout the investigational period, and for 6 months after final ASP2138 administration (or follow the contraception...
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final ASP2138 intervention...
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final ASP2138 intervention...
- Male participant must not donate sperm during the treatment period and for 6 months after ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing...
- Participant has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to the first dose of study intervention per investigator assessment.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participant has a corrected QT interval by Fridericia (QTcF) ≤ 470 msec.
- Participant must meet all of the criteria based on laboratory tests within 7 days prior to the first dose of study intervention. Participant has adequate organ and marrow function. If a participant has received a recent...
- Participant agrees not to participate in another treatment study while receiving study intervention in the present study.
What rules you out
- 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...
- 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.
- Participant has another malignancy for which treatment is required.
- Participant has a history or complication of interstitial lung disease.
- Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
- Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. NOTE: Applicable if participant is receiving fluoropyrimidine containing chemotherapy. Screening for DPD deficiency should be conducted per local...
- Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with full dose warfarin (coumadin) is not allowed.
- Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).
- Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade ≥ 2 bleeding events in the month prior to treatment).
- Participant has uncontrolled intercurrent illness or infection.
- Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with cluster of differentiation (CD) 4+ T cell counts ≥ 350 cells/µL and no history of acquired immunodeficiency syndrome...
- Participant is known to have active hepatitis B (positive hepatitis B surface antigen [hBsAg]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements...
- For participant who is negative for hBsAg, but hepatitis B core (HBc) Ab positive, an HBV DNA test will be performed and if positive the participant will be excluded.
- Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.
- Participant treated for HCV with undetectable viral load results is eligible.
- Participant has a known history of UGT1A1 gene polymorphism resulting in complete loss of function of the UGT1A1 gene product (for participants receiving irinotecan containing chemotherapy).
- Participant has any pre-existing severe gastric conditions such as active gastritis or ulcer that could be exacerbated by treatment.
- Participant has received any prior chemotherapy, radiation therapy, immunotherapy, or biologic ("targeted") therapy or investigational therapy for treatment of the participant's pancreatic tumor.
- Participant has received a live vaccine within 30 days of planned start of study therapy. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed.
- Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study...
- Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.
- Participant has had a major surgical procedure 28 days before start of study intervention and has not fully recovered.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.