This study is looking at people with advanced solid cancers that are known to produce a tumor marker called CA19-9. The types of cancer included in this study are pancreatic adenocarcinoma, cancer of the bile ducts, cancer of the bladder and urinary tract, colorectal adenocarcinoma, cancer of the area where the esophagus meets the stomach, endometrial carcinoma, and epithelial ovarian cancer. The treatment being tested is an investigational drug called BNT329, which is given through an intravenous infusion, meaning it is delivered directly into a vein. The purpose of this study is to find out if BNT329 is safe and to see if it might help control or shrink these tumors.
The study is divided into different parts. In the first parts, called Part A, Part B, and Part C, researchers will test different doses of the drug to find out which dose is safe and works best. They will carefully watch for any side effects and see how the body processes the drug. In Part D, the study will focus specifically on people with pancreatic adenocarcinoma and will look more closely at whether the drug helps shrink tumors or stop them from growing. During the study, participants will receive the study drug and will have regular check-ups to monitor their health and see how the cancer is responding to treatment.
Throughout all parts of the study, doctors will measure how much of the drug is in the blood, watch for any unwanted effects, and check if the cancer gets better, stays the same, or gets worse. They will also test whether the body develops an immune response to the drug over time. The study will track how long any positive effects last and whether people need to stop treatment or change their dose because of side effects. All participants must have already tried standard treatments that are normally used for their type of cancer, and those treatments must not have worked well enough or must no longer be available as an option.



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