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A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
MinorTrial sites expanded: 62 → 79 locationsEligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 13 of 17 entriesShow 2 more changesShow less
Eligibility criteria expanded, about 19 words
Secondary endpoints: details revised at 13 of 17 entries
MinorTrial sites expanded: 48 → 62 locationsv11
MinorTrial sites expanded: 34 → 48 locationsv10
MinorTrial sites expanded: 29 → 34 locationsTrial sites expanded: 17 → 29 locationsv9Show 1 more changeShow less
Trial sites expanded: 17 → 29 locations
MinorStudy sites: 17 to 29v8
MinorRe-verified, no change to tracked fieldsv7
MinorTrial sites expanded: 13 → 17 locationsv6
MinorTrial sites expanded: 10 → 13 locationsv5
MinorTrial sites expanded: 7 → 10 locationsv4
MinorStudy sites: 2 to 7v3
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 2 · Start date changed from estimate of Feb 28, 2026 to Feb 17, 2026 · Eligibility criteria revised · 2 morev2Show 5 more changesShow less
Study sites: 0 to 2
Start date changed from estimate of Feb 28, 2026 to Feb 17, 2026
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.