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New drug targets genetic weakness in tough pancreatic cancer

NCT ID NCT07409272

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether adding setidegrasib (ASP3082) to standard chemotherapy helps people with a specific KRAS G12D mutation in metastatic pancreatic cancer live longer. About 614 adults will be randomly assigned to receive either setidegrasib or a placebo, along with chemotherapy. The study aims to see if the combination delays cancer growth and improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
setidegrasib (ASP3082)
What this could lead to
If it works, this could lead to a new targeted treatment option for people with a specific genetic mutation in pancreatic cancer, potentially extending life when combined with chemotherapy.
What could go wrong
This is a large phase 3 trial, but the drug is still experimental. It may not improve survival or could cause side effects. The benefit depends on the specific KRAS G12D mutation, which not all patients have.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 614 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization). * Participant has no option for surgical resection or radiotherapy with curative intent. * Participant consents to and provides a baseline tumor tissue specimen for the study during screening. The sample must meet the requirements described in the laboratory manual and the tumor sample guidance. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days prior to randomization. * Participant has adequate organ function as indicated by the following laboratory values within 7 days prior to randomization (if a participant has received a recent blood transfusion, the latest laboratory tests must be obtained ≥ 14 days after any blood transfusion). The laboratory values prior to the initiation of the first dose of setidegrasib/placebo (or mFOLFIRINOX/NALIRIFOX, if chemotherapy is administered during the screening period) should be used to determine eligibility. Participants who receive mFOLFIRINOX/NALIRIFOX during the screening period must meet these criteria within 7 days prior to the start of on-treatment chemotherapy (i.e., C1D1). * Participant agrees not to participate in another interventional study while receiving study intervention in the present study (participant who is currently in the follow-up period of an interventional clinical trial is allowed). Exclusion Criteria: * Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous/adenosquamous features. * Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed. * Participant has chronic inflammatory bowel disease, bowel obstruction and/or severe uncontrolled diarrhea. * Participant has peripheral sensory neuropathy with functional impairment. * Participant has ascites and/or pleural effusion that require invasive interventions within 30 days prior to randomization or have an indwelling drainage catheter. * Participant has symptomatic pulmonary embolism or pulmonary embolism not being treated with anticoagulation. * Participant has a history of interstitial lung disease or pulmonary fibrosis. * Participant has uncontrolled seizure disorder or refractory to antiepileptics. * Participant has known homozygous uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism. * Participant has had a myocardial infarction, unstable angina or coronary artery bypass surgery within 6 months prior to randomization or currently has an uncontrolled illness including but not limited to symptomatic congestive heart failure, clinically significant cardiac disease (e.g., cardiomyopathy, infiltrative cardiac disease, etc.), unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker or long QT interval (QT) syndrome. * Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses \[i.e., 28 days; 1 cycle\] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received \[neo\]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the \[neo\]adjuvant therapy). * Participant has had prior treatment with a KRAS G12D-targeted agent. * Participant has a corrected QT interval by Fridericia (QTcF) (single electrocardiogram \[ECG\]) \> 470 msec during the screening period.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic pancreatic adenocarcinoma Metastatic pancreatic cancer Pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    62 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AGH Singer Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Aichi Cancer Center

    RECRUITING

    Nagoya, Japan

  • Allina Health Cancer Institute - Hematology Cancer Care Services

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Atlantic Health - Overlook Medical Center

    RECRUITING

    Morristown, New Jersey, 07962, United States

  • Baptist Health Medical Group Oncology

    RECRUITING

    Miami, Florida, 33176, United States

  • Baptist MD Anderson Cancer Institute

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Brown University Health Cancer Institute - Division of Hematology/Oncology

    RECRUITING

    Providence, Rhode Island, 02906, United States

  • Cedars-Sinai - Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Chugoku-Shikoku Group - Shikoku Cancer Center

    RECRUITING

    Matsuyama, Ehime, Japan

  • Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton

    RECRUITING

    Fullerton, California, 92835, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Facilities Design and Construction - Energy Advancement and Innovation Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Fred Hutchinson Cancer Center - Advanced Cancer Research Group

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fudan University Shanghai Cancer Center - Xuhui Campus

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Hartford Healthcare

    RECRUITING

    Hartford, Connecticut, 06016, United States

  • HealthPartners Cancer Center at Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • HealthPartners Frauenshuh Cancer Center

    RECRUITING

    Saint Louis Park, Minnesota, 55426, United States

  • Hoag Mem Hosp Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Houston Methodist Office of Graduate - Houston Methodist Neal Cancer Center at Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Indiana University Health - Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Inova Schar Cancer Institute Clinical Trials

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Japanese Foundation for Cancer Research - The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto, Tokyo, Japan

  • Keio University Hospital

    RECRUITING

    Tokyo, Japan

  • Kindai University Hospital

    RECRUITING

    Sakai, Osaka, Japan

  • Kyushu Group - Kyushu Cancer Center

    RECRUITING

    Fukuoka, Fukuoka, Japan

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Memorial Sloan Kettering - Hackensack - Memorial Sloan Kettering Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center - Main Campus

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center - Monmouth

    RECRUITING

    Middletown, New Jersey, 00748-3052, United States

  • Memorial Sloan Kettering Commack

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    RECRUITING

    Harrison, New York, 10604, United States

  • Mercy CH Chub O'Reilly Cancer Center

    RECRUITING

    Springfield, Missouri, 65804, United States

  • Mercy Cancer Center

    RECRUITING

    Fort Smith, Arkansas, 72903, United States

  • Mercy David C. Pratt Cancer Center - St. - Mercy Research - David C. Pratt Cancer Center

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Mercy Hospital Oklahoma City - Mercy Coletta Cancer Center - Oklahoma City

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Mount Sinai Medical Center - Miami Beach

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • NYU Long Island Mineola

    RECRUITING

    Mineola, New York, 11501, United States

  • Nara Medical University Hospital

    RECRUITING

    Kashihara-shi, Nara, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, Japan

  • Oregon Health & Science University - OHSU Knight Cancer Institute

    RECRUITING

    Portland, Oregon, 97201, United States

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    RECRUITING

    Osaka, Japan

  • Piedmont Healthcare - Piedmont Physicians Medical Oncology Atlanta

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • Saint Joseph Hospital - Cancer Centers - St. Vincent Frontier Cancer Center

    RECRUITING

    Billings, Montana, 59102, United States

  • The Alvin J. Siteman Cancer Center - Center for Advanced Med

    RECRUITING

    St Louis, Missouri, 63110, United States

  • The University of Osaka Hospital

    RECRUITING

    Suita, Osaka, Japan

  • The University of Tokyo Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, Japan

  • UC Irvine Health-Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868-3201, United States

  • UCI Health - Irvine

    RECRUITING

    Irvine, California, 92612, United States

  • UT Southwestern Medical Center at Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

  • UVA Emily Couric Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Arizona Cancer Center - North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Maryland School - Division of Hematology/Oncology

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan Health - University of Michigan Medical Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14611, United States

  • Utah Cancer Specialists

    RECRUITING

    Salt Lake City, Utah, 84106, United States

  • Virginia Mason Franciscan Health - Virginia Mason Medical Center

    RECRUITING

    Seattle, Washington, 98101, United States

  • White Plains Hospital Center for Cancer Care - Oncology

    RECRUITING

    White Plains, New York, 10601, United States

  • Yamaguchi University Hospital

    RECRUITING

    Ube-shi, Yamaguchi, Japan

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