In this study, everyone receives a medicine called EVOLVE104 through an IV, which means it goes into a vein. This is an open label study, so everyone knows the drug and dose they are getting. Each infusion takes about one hour, and doctors will watch you closely during the infusion and for up to two days after it, especially at the beginning. The first three doses are given one week apart. After that, the doses are given every week or every two weeks in 28 day cycles. Early doses may require staying in the hospital overnight and may start at a lower amount that increases slowly to help your body adjust. During the study, you will have regular checkups, blood tests, heart tests, scans every eight weeks, and eye exams. The study has different stages, including screening, treatment, end of treatment, and long term follow up. Screening can last up to 28 days and includes exams, blood tests, heart tests, eye exams, and scans to make sure you can join the study.

This study is for adults who have advanced urothelial cancer or squamous cell carcinoma. These cancers have either not responded to earlier treatments or have come back after treatment.

This study is for people who have advanced urothelial or squamous cell cancer that did not get better with earlier treatments or has come back. People cannot join if they have infections like hepatitis B, hepatitis C, or HIV. They cannot be pregnant or breastfeeding, and they must agree to use birth control during treatment and for 120 days after the last dose. They cannot take other experimental treatments while in the study, cannot get live vaccines close to the first dose or during the study, and cannot take strong immune‑suppressing medicines unless the study doctor approves it. People must also be able to come to study visits, share their medical history, list their medicines, and tell the study team about any health changes.

This study is testing a new immunotherapy medicine called EVOLVE104. It is designed to help the body’s T cells find and kill cancer cells. Researchers want to learn if the medicine is safe and how well it works for different types of cancer. They also want to find the best dose to use. The study will measure how much of the drug is in the blood and whether the body makes antibodies against it.