Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

To be considered for this study, you must have advanced pancreatic cancer that has spread to other parts of your body, and this diagnosis must have been made within the last three months. You shouldn't have had previous treatment for this widespread cancer, though you might have had surgery (like a Whipple procedure) or chemotherapy before if it was for earlier-stage cancer.

You should be at least 18 years old and generally well enough to manage daily activities, with a good chance of living for at least another three months. Doctors will need to see that your cancer can be measured on scans (like CT or MRI). Your body should also be working well enough to handle the treatment, which includes your blood count, liver, and kidney function.

There are also some reasons why you might not be able to join. For example, if you are known to have specific genetic mutations (changes in your genes like BRCA 1/2), you might not be suitable. Women who could become pregnant will need to take a pregnancy test and use reliable contraception throughout the study.

If you join this study, you will be randomly assigned to one of two groups: either you'll receive the new drug SBP-101 plus standard chemotherapy, or you'll receive a placebo (a dummy drug) plus standard chemotherapy. You and your doctor won't know which group you're in. The treatments will involve regular visits to the hospital for medications and check-ups. You'll have various tests, including blood checks and scans (like CT or MRI), to monitor your health and how the treatment is working. We will also ask you to complete questionnaires to understand your quality of life. The exact number of visits and the total duration will depend on your individual response and how long you continue with the treatment, but the full study length could be several years for all participants to be followed up.