OncoMatch/Clinical Trials/NCT07409272
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
Is NCT07409272 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for pancreatic cancer.
Treatment: Setidegrasib · Oxaliplatin · Leucovorin · Irinotecan · fluorouracil · liposomal irinotecan — 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. 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: KRAS G12D
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)
Excluded: UGT1A1 homozygous polymorphism
known homozygous uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism
Disease stage
Required: Stage IV
Metastatic disease required
histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC); no option for surgical resection or radiotherapy with curative intent
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: KRAS G12D-targeted agent
prior treatment with a KRAS G12D-targeted agent
Cannot have received: systemic therapy
Exception: up to 2 doses (28 days; 1 cycle) of mFOLFIRINOX or NALIRIFOX during the screening period allowed; if [neo]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose
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)
Lab requirements
Blood counts
adequate organ function as indicated by laboratory values within 7 days prior to randomization (see protocol/lab manual for specifics)
Kidney function
adequate organ function as indicated by laboratory values within 7 days prior to randomization (see protocol/lab manual for specifics)
Liver function
adequate organ function as indicated by laboratory values within 7 days prior to randomization (see protocol/lab manual for specifics)
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baptist MD Anderson Cancer Institute · Jacksonville, Florida
- HealthPartners Frauenshuh Cancer Center · Saint Louis Park, Minnesota
- HealthPartners Cancer Center at Regions Hospital · Saint Paul, Minnesota
- NYU Long Island Mineola · Mineola, New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone · New York, New York
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