A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

This study is looking for adults aged 18 or over in the UK who have pancreatic cancer that has spread to other parts of their body. A key requirement is that your cancer must have a specific change in its genes, called the KRAS G12D mutation. This would be checked with a test on your tumour tissue. Also, surgery or radiotherapy must not be an option that could cure your cancer.

You would need to be generally well enough to take part, meaning you have good overall health and your organs (like your liver and kidneys) are working properly. You also can't be taking part in another study at the same time where you're receiving a new treatment.

However, you wouldn't be able to join this study if your cancer has spread to the lining of your brain or spinal cord, or if you have symptoms from cancer in your brain or nervous system. You also can't have had other cancers recently that needed treatment, or have certain other rare types of pancreatic cancer.

If you decide to take part, you will receive a new drug called setidegrasib or a dummy drug (placebo), along with standard chemotherapy (either mFOLFIRINOX or NALIRIFOX). Which one you receive – setidegrasib or placebo – will be decided by chance, like flipping a coin. Your study doctor will decide which chemotherapy is best for you.

All study treatments are given slowly through a tube into a vein, usually in your arm (an infusion). You will have regular visits to the hospital for your treatments, safety checks, and to monitor your health and the cancer. These visits will involve blood tests, scans, and doctors checking how you are feeling. You will continue treatment for as long as it's helping you and you're not having serious side effects. You can stop participating at any time, for any reason, if you wish to.