The study focuses on adults with metastatic pancreatic adenocarcinoma that carries the KRAS G12D genetic change. Participants receive a combination of the experimental drug ASP3082 given by intravenous infusion together with one of two standard chemotherapy regimens, either mFOLFIRINOX or NALIRIFOX. For comparison, another group receives the same chemotherapy plus a simple sugar solution, Dextrose 5% in water solution for infusion, which serves as a control.
The purpose of the study is to determine whether adding ASP3082 to chemotherapy can improve overall survival compared with chemotherapy alone. Participants are randomly assigned to one of the two treatment groups and receive study medication and chemotherapy in cycles over several months, with regular check‑ups to monitor health, side effects, and any changes in tumor size. The study follows participants from the start of treatment until its end, recording outcomes and safety information throughout.
1randomization
after enrollment you are randomly assigned to receive either asp3082 (the test drug) or a placebo (dextrose 5% solution). both options are given together with either mfolfirinox or nalirifox chemotherapy regimens.
2start of treatment cycles
each chemotherapy cycle you receive an intravenous infusion of the assigned study drug.
asp3082 is provided as a concentrate for solution for infusion at a dose of 0000 mg per infusion.
the placebo is dextrose 5% in water solution for infusion, administered in the same manner.
the infusion is given once per chemotherapy cycle, typically every two weeks, and continues until disease progression, unacceptable side effects, or the end of the study.
3pre‑infusion safety checks
before each infusion, laboratory tests, vital signs, electrocardiograms (ecg), and performance status are measured to ensure safety.
4tumor assessment
periodic imaging scans are performed to evaluate tumor size and determine progression‑free survival and response to treatment.
5ongoing safety monitoring
throughout the study any adverse events, serious adverse events, and changes in laboratory results are recorded and evaluated.
6end of treatment and follow‑up
when treatment stops because of progression, toxicity, or study completion, follow‑up visits continue to collect information on overall survival, which is the time from randomization until death from any cause.
Who Can Join the Study?
You must have pancreatic cancer that has spread to other parts of the body (metastatic PDAC) and a laboratory test must have confirmed the presence of a specific genetic change called the KRAS G12D mutation; “histologically confirmed” means a tissue sample was examined under a microscope to verify the diagnosis.
The cancer cannot be removed by surgery or cured with radiation therapy that is intended to be curative.
The KRAS G12D mutation must be identified in a tissue sample (such as a biopsy) using a local or central laboratory test.
You must have an ECOG Performance Status of 0 or 1, which means you are either fully active (0) or able to do light work and carry out most daily activities (1) within the week before joining the study.
Your recent blood tests must show that your major organs (liver, kidneys, bone marrow, etc.) are working well enough, referred to as “adequate organ function.”
You must be an adult (generally 18 years of age or older); both men and women are eligible.
Who Cannot Join the Study?
You have a type of pancreatic cancer that is not the specific kind being studied, such as neuroendocrine (cancer from hormone‑producing cells), acinar pancreatic carcinoma (cancer from enzyme‑producing cells), or pancreatic cancer with squamous/adenosquamous features (cancers with certain cell types).
You have low or no activity of the enzyme DPD (dihydropyrimidine dehydrogenase), which is needed to break down some chemotherapy medicines.
You have two copies (homozygous) of a gene change called UGT1A1 polymorphism, which can affect how your body processes certain drugs.
You have received any radiotherapy (radiation treatment) within the 14 days before the study would start.
You have already had systemic therapy (treatment that goes throughout the whole body) for your metastatic pancreatic cancer, except for a very short course (up to 28 days) of the study’s chemotherapy regimens mFOLFIRINOX or NALIRIFOX during the screening period, or if you had earlier chemotherapy after surgery (neo‑adjuvant chemotherapy) the cancer must have come back at least 6 months after finishing that treatment.
You have previously been treated with a drug that specifically targets the KRAS G12D mutation.
ASP3082 is an experimental medication being tested for the first time in this study. It contains a substance called setidegrasib and is given through an IV infusion. Researchers hope that ASP3082 may help slow the growth of pancreatic cancer that has a specific KRAS G12D mutation when it is used together with standard chemotherapy.
mFOLFIRINOX is a standard chemotherapy regimen that combines several drugs—fluorouracil, irinotecan, oxaliplatin, and leucovorin—delivered by IV infusion. In this trial, it is used as the backbone treatment for pancreatic cancer, and the study is looking at whether adding ASP3082 improves patients’ overall survival.
NALIRIFOX is another chemotherapy regimen similar to FOLFIRINOX but includes nab‑paclitaxel (albumin‑bound paclitaxel) along with the other chemotherapy agents. It is also given by IV infusion and serves as the main chemotherapy treatment in the study, allowing researchers to compare outcomes when ASP3082 is added to this regimen.
Metastatic pancreatic ductal adenocarcinoma (KRAS G12D mutation) – This cancer starts in the cells that line the pancreas and has spread to other parts of the body. The tumor grows by forming new blood vessels that feed its expansion. Cancer cells can move from the original site to distant organs, creating secondary growths. As the disease advances, the number of cancer cells in the bloodstream often increases. The KRAS G12D mutation makes the tumor cells divide more quickly and resist normal growth controls.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
France 
Germany 
Italy 
Poland 
Spain 
