Clinical Trials Directory

We are doing this study to test the safety and effectiveness of the study drug, datopotamab deruxtecan (also known as dato-DXd), and find out if it is a potential option for patients with metastatic breast cancer that has spread to the brain and/or spinal cord.

The study team will collect medical record information from your hospitalization for pneumonia. You will also be asked to provide a urine (pee) sample for additional testing.

Participants will be admitted to the Duke Early Phase Unit for 2 nights, and receive an infusion of either the study drug or placebo. Safety will be monitored for at least 24 hours after the infusion, and there will be numerous blood draws.

This study starts with a screening visit to see if a person can join. After that, there are thirteen study visits over about twenty weeks. During this time, participants will receive three shots of the study medicine called DISC 3045 given under the skin. All study visits include blood tests, and one visit will include two blood draws. People may also choose to stay in the study longer for another twelve weeks. If they continue, they will receive three more shots of the study medicine and have seven more study visits with blood tests.

In this study, people will be placed into one of two groups by chance, like flipping a coin. One group will receive a medicine called nipocalimab, and the other group will receive a placebo, which looks the same but has no medicine. The medicine is given through a vein every two weeks for about 24 weeks. During the study, participants will have clinic visits, blood tests, exams, and answer questions about how they feel. After this part is finished, some people may have the option to continue in another part of the study and receive the study medicine.

In this study, people will be placed into one of two groups by chance. One group will receive the study medicine and the other group will receive a placebo, which has no active medicine. The study medicine is given one or two times through a small needle in the lower back into the area around the spinal cord. The medicine is designed to lower a protein that builds up in the brains of people with Alzheimer disease. Participants will stay in the research center for a few days during treatment so doctors can watch them closely. They will also need to have a study partner who can go with them to many of the study visits.