ASP3082-0301: A Phase 3 study of Efficacy and Safety in Pancreatic Cancer
Research type
Research Study
Full 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
IRAS ID
1013303
Contact name
Head of Clinical Trial Unit
Contact email
Sponsor organisation
Astellas Pharma Global Development Incorporated
Eudract number
2025-523684-38
Clinicaltrials.gov Identifier
Research summary
Pancreatic cancer is a serious illness with one of the lowest survival rates among cancers. It is becoming more common in the United States and worldwide. In 2022, more than half a million people were diagnosed, and almost the same number died from the disease.
Many pancreatic cancers are linked to changes (mutations) in specific genes. One of the most common changes is in a gene called KRAS, and a type called KRAS G12D is found in about 40% of cases. This type is linked to a poorer outlook. Right now, there are no approved treatments that specifically target KRAS G12D.
This study is looking at a new medicine called ASP3082, which is designed to target the KRAS G12D mutation directly. ASP3082 will be given with chemotherapy (either mFOLFIRINOX or NALIRIFOX) as the first treatment for people with KRAS G12D–positive pancreatic cancer that has spread. Researchers want to see if using ASP3082 is safe, and whether it can help people live longer than with chemotherapy alone.
Over 600 people with KRAS G12D–positive pancreatic cancer will be invited to take part in this study which is being run at approximately 250 sites globally. Participants will either receive the study drug in combination with chemotherapy, or a placebo with chemotherapy. Participants will be put into one of these treatment groups randomly and neither the participant nor the study doctor will know which group they are in. This helps prevent bias.
There is no set time for how long participants will be in this study. It will depend on their health. Participants will need to visit the study site about once a week.
Participants condition might get better, get worse, or stay the same in this study. However, the information researchers get from this study may be useful for others taking this drug in the future.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
26/YH/0081
Date of REC Opinion
15 May 2026
REC opinion
Further Information Favourable Opinion