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

NCT07024615 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2138-CL-0102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Claudin (CLDN) 18.2; ASP2138; Safety; Tolerability

Outcome Measures

Primary Outcomes (8)

• 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.

  Up to 11.5 months

• 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.

  Up to 11.5 months

• Number of participants with laboratory value abnormalities and/or AEs

  Number of participants with potentially clinically significant laboratory values.

  Up to 11.5 months

• Number of participants with vital signs abnormalities and/or AEs

  Number of participants with potentially clinically significant vital sign values.

  Up to 11.5 months

• Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs

  Number of participants with potentially clinically significant 12-Lead ECG values.

  Up to 10.5 months

• Number of participants with physical examinations (PEs) abnormalities and/or AEs

  Number of participants with potentially clinically significant PEs values.

  Up to 11.5 months

• Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score

  The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

  Up to 11.5 months

• Number of participants with ASP2138-related surgery delays (≥ 7 days)

  Surgery delay is defined as the interval (in days) between the pre-specified planned date of surgery and the actual date on which surgery is performed. Delays of ≥ 7 days that are assessed by the investigator as being related to ASP2138 (treatment-related) will be documented.

  Up to 12 weeks after the end of neoadjuvant treatment

Secondary Outcomes (4)

• Pharmacokinetics (PK) of ASP2138 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)

  Up to 0.5 month

• Number of participants at each grade of Pathologic Response

  Up to 10.5 months

• Disease-free survival (DFS)

  Up to 11.5 months

• Number of participants with microscopically margin-negative (R0) resection

  Up to 10.5 months

Study Arms (1)

ASP2138 and investigator's choice of adjuvant chemotherapy

EXPERIMENTAL

Participants will receive ASP2138 for up to 2 weeks prior to surgery. Following surgery participants will receive adjuvant chemotherapy (either mFOLFIRINOX \[modified leucovorin (folinic acid), 5-FU (fluorouracil), irinotecan and oxaliplatin\], Gemcitabine/Nab-paclitaxel, or Gemcitabine/Capecitabine) for up to 6 months or until meeting treatment discontinuation criteria.

Drug: ASP2138; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FU; Drug: Irinotecan; Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Capecitabine

Interventions

Capecitabine DRUG

Oral

ASP2138 and investigator's choice of adjuvant chemotherapy

ASP2138 DRUG

Subcutaneously

ASP2138 and investigator's choice of adjuvant chemotherapy

Oxaliplatin DRUG

Injection

ASP2138 and investigator's choice of adjuvant chemotherapy

Leucovorin DRUG

Injection

Also known as: Folinic Acid

ASP2138 and investigator's choice of adjuvant chemotherapy

5-FU DRUG

Injection

Also known as: Fluorouracil

ASP2138 and investigator's choice of adjuvant chemotherapy

Irinotecan DRUG

Injection

ASP2138 and investigator's choice of adjuvant chemotherapy

Gemcitabine DRUG

Intravenously

ASP2138 and investigator's choice of adjuvant chemotherapy

Nab-paclitaxel DRUG

Intravenously

ASP2138 and investigator's choice of adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 York Heart Association Functional Classification.
• 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 follow the contraception requirements per the adjuvant chemotherapy package insert \[PI\]/prescribing information, whichever is longer).
• 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 contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
• 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 requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
• 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 administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
• 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 administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
• 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 information, whichever is longer).
• 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.

You may not qualify if:

• 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.
• 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 requirements.
• 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 (AIDS) defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for HIV infection should be conducted per local requirements.
• 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. NOTE: Screening for these infections should be conducted per 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Irinotecan; Gemcitabine; 130-nm albumin-bound paclitaxel; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Associate Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development, Inc.

CONTACT

800-888-7704; Astellas.registration@astellas.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)