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RECRUITING

NCT07409272

PHASE3

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Sponsor: Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. The first treatment that people usually receive is chemotherapy. At the time this study started, some of the main standard chemotherapies for pancreatic cancer were mFOLFIRINOX or NALIRIFOX. Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with pancreatic cancer have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation. This study is about setidegrasib given with chemotherapy in people with pancreatic cancer who have the KRAS G12D mutation. Before setidegrasib can become an approved treatment, clinical studies need to be completed to understand how it works and how safe it is. The main aim is to learn if people who are given setidegrasib with chemotherapy live for longer than people who are given placebo with chemotherapy. Other aims are to learn if setidegrasib delays the cancer and symptoms returning, how the body processes setidegrasib, and its safety, when given with chemotherapy. People in this study will be adults with metastatic pancreatic cancer with the G12D mutation in their KRAS gene. Surgery or radiotherapy will not be an option to cure their cancer. People cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or have recently had some other cancers that required treatment. In this study, people are given either setidegrasib with mFOLFIRINOX or NALIRIFOX chemotherapy, or a placebo with mFOLFIRINOX or NALIRIFOX chemotherapy. Whether people receive setidegrasib or placebo is decided by chance. The study doctor decides which chemotherapy (mFOLFIRINOX or NALIRIFOX) people receive. People will only receive NALIRIFOX chemotherapy (with setidegrasib or placebo) after the safety of setidegrasib with NALIRIFOX chemotherapy has been confirmed in another ongoing setidegrasib study. All of the study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study.

Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

614

Start Date

2026-02-17

Completion Date

2029-08-31

Last Updated

2026-08-27

Healthy Volunteers

Conditions

Pancreatic Cancer Metastatic Pancreatic Cancer Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

Setidegrasib

Intravenous infusion

DRUG

Oxaliplatin

Intravenous infusion

DRUG

Leucovorin

Intravenous infusion

DRUG

Irinotecan

Intravenous infusion

DRUG

fluorouracil

Intravenous infusion

DRUG

liposomal irinotecan

Intravenous infusion

DRUG

Placebo

Intravenous Infusion

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.

Locations (62)

University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

Mercy Cancer Center

Fort Smith, Arkansas, United States

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

Fullerton, California, United States

UCI Health - Irvine

Irvine, California, United States

Cedars-Sinai - Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Mem Hosp Presbyterian

Newport Beach, California, United States

UC Irvine Health-Chao Family Comprehensive Cancer Center

Orange, California, United States

Hartford Healthcare

Hartford, Connecticut, United States

Baptist MD Anderson Cancer Institute

Jacksonville, Florida, United States

Baptist Health Medical Group Oncology

Miami, Florida, United States

Mount Sinai Medical Center - Miami Beach

Miami Beach, Florida, United States

Piedmont Healthcare - Piedmont Physicians Medical Oncology Atlanta

Atlanta, Georgia, United States

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

Indianapolis, Indiana, United States

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

Edgewood, Kentucky, United States

University of Maryland School - Division of Hematology/Oncology

Baltimore, Maryland, United States

University of Michigan Health - University of Michigan Medical Center

Ann Arbor, Michigan, United States

Allina Health Cancer Institute - Hematology Cancer Care Services

Minneapolis, Minnesota, United States

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

Mercy CH Chub O'Reilly Cancer Center

Springfield, Missouri, United States

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

St Louis, Missouri, United States

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

St Louis, Missouri, United States

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

Billings, Montana, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering - Hackensack - Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Atlantic Health - Overlook Medical Center

Morristown, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

NYU Long Island Mineola

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

University of Rochester

Rochester, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

White Plains Hospital Center for Cancer Care - Oncology

White Plains, New York, United States

Facilities Design and Construction - Energy Advancement and Innovation Center

Columbus, Ohio, United States

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

Oklahoma City, Oklahoma, United States

Oregon Health & Science University - OHSU Knight Cancer Institute

Portland, Oregon, United States

AGH Singer Research Institute

Pittsburgh, Pennsylvania, United States

Brown University Health Cancer Institute - Division of Hematology/Oncology

Providence, Rhode Island, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

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

Houston, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

UVA Emily Couric Cancer Center

Charlottesville, Virginia, United States

Inova Schar Cancer Institute Clinical Trials

Fairfax, Virginia, United States

Virginia Mason Franciscan Health - Virginia Mason Medical Center

Seattle, Washington, United States

Fred Hutchinson Cancer Center - Advanced Cancer Research Group

Seattle, Washington, United States

Fudan University Shanghai Cancer Center - Xuhui Campus

Shanghai, Shanghai Municipality, China

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Chugoku-Shikoku Group - Shikoku Cancer Center

Matsuyama, Ehime, Japan

Kyushu Group - Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Kindai University Hospital

Sakai, Osaka, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

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

Koto, Tokyo, Japan

Yamaguchi University Hospital

Ube-shi, Yamaguchi, Japan

Aichi Cancer Center

Nagoya, Japan

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, Japan

Keio University Hospital

Tokyo, Japan

Clinical Research Directory

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (62)