A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony zaawansowany rak trzustki (typ adenokarcinoma) z mutacją KRAS G12D
- •Operacja lub radioterapia nie są możliwe do wyleczenia raka
- •Dobry ogólny stan zdrowia (zdolność do wykonywania codziennych aktywności)
- •Prawidłowe funkcjonowanie nerek, wątroby i innych organów wg badań krwi
- •Wyrażenie zgody na pobranie próbki nowotworu do badania przed rozpoczęciem leczenia
- •Brak uczestnictwa w innym badaniu klinicznym podczas trwania tego badania
✗ Disqualifies
- •Inne typy raka trzustki (nie adenokarcinoma klasyczna)
- •Inne nowotwory wymagające leczenia w ciągu ostatnich 2 lat
- •Rak rozprzestrzeniający się na oponę mózgową lub rdzeń kręgowy
- •Objawy raka mózgu lub choroby układu nerwowego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 27, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (48)
University of Arizona Cancer Center - North Campus
Tucson, United States
Mercy Cancer Center
Fort Smith, United States
Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton
Fullerton, United States
Cedars-Sinai - Cedars-Sinai Medical Center
Los Angeles, United States
Hoag Mem Hosp Presbyterian
Newport Beach, United States
Hartford Healthcare
Hartford, United States
Baptist MD Anderson Cancer Institute
Jacksonville, United States
Baptist Health Medical Group Oncology
Miami, United States
Mount Sinai Medical Center - Miami Beach
Miami Beach, United States
Indiana University Health - Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, United States
Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care
Edgewood, United States
University of Maryland School - Division of Hematology/Oncology
Baltimore, United States
University of Michigan Health - University of Michigan Medical Center
Ann Arbor, United States
Allina Health Cancer Institute - Hematology Cancer Care Services
Minneapolis, United States
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul, United States
Mercy CH Chub O'Reilly Cancer Center
Springfield, United States
The Alvin J. Siteman Cancer Center - Center for Advanced Med
St Louis, United States
Mercy David C. Pratt Cancer Center - St. - Mercy Research - David C. Pratt Cancer Center
St Louis, United States
Saint Joseph Hospital - Cancer Centers - St. Vincent Frontier Cancer Center
Billings, United States
Dartmouth Hitchcock Medical Center
Lebanon, United States
Atlantic Health - Overlook Medical Center
Morristown, United States
NYU Long Island Mineola
Mineola, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, United States
University of Rochester
Rochester, United States
White Plains Hospital Center for Cancer Care - Oncology
White Plains, United States
Facilities Design and Construction - Energy Advancement and Innovation Center
Columbus, United States
Mercy Hospital Oklahoma City - Mercy Coletta Cancer Center - Oklahoma City
Oklahoma City, United States
AGH Singer Research Institute
Pittsburgh, United States
Brown University Health Cancer Institute - Division of Hematology/Oncology
Providence, United States
UT Southwestern Medical Center at Dallas
Dallas, United States
Houston Methodist Office of Graduate - Houston Methodist Neal Cancer Center at Texas Medical Center
Houston, United States
Utah Cancer Specialists
Salt Lake City, United States
UVA Emily Couric Cancer Center
Charlottesville, United States
Inova Schar Cancer Institute Clinical Trials
Fairfax, United States
Virginia Cancer Specialists
Fairfax, United States
Virginia Mason Franciscan Health - Virginia Mason Medical Center
Seattle, United States
Fred Hutchinson Cancer Center - Advanced Cancer Research Group
Seattle, United States
National Cancer Center Hospital East
Kashiwa, Japan
Chugoku-Shikoku Group - Shikoku Cancer Center
Matsuyama, Japan
Kyushu Group - Kyushu Cancer Center
Fukuoka, Japan
Nara Medical University Hospital
Kashihara-shi, Japan
The University of Osaka Hospital
Suita, Japan
The University of Tokyo Hospital
Bunkyo-ku, Japan
Japanese Foundation for Cancer Research - The Cancer Institute Hospital of JFCR
Koto, Japan
Yamaguchi University Hospital
Ube-shi, Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, Japan
Trial contact
Astellas Pharma Global Development, Inc.
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/28/2026.
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