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We are doing this study to find out if the Nectero EAST System® (the study procedure) is a safe and effective option for treating abdominal aortic aneurysms that are small to medium in size.
If you participate, you will be asked to provide a blood draw of about 5.4 mL, or 1/3 tablespoon, of blood. If you are one of the first 20 subjects, you may have the chance to participate in one additional blood draw.
This study has three parts, called Sub-Studies. In Sub-Study 1, people receive a medicine called duvakitug. In Sub-Study 2, people are placed by chance into one of three groups and may get duvakitug, a placebo with no medicine, or both depending on the group. In Sub-Study 3, people are placed by chance into one of two groups to get different doses of duvakitug. The whole study lasts about thirty-five weeks and includes fifteen clinic visits. During these visits, people will have tests such as heart checks, blood tests, endoscopy, biopsies, and questionnaires. Depending on when a person joins, they will be placed in Sub-Study 1 or Sub-Study 2. In both of these, they will take the study drug every two weeks for twelve weeks. After finishing one of these parts, they may be asked to join Sub-Study 3 for another twelve weeks of treatment, or they may be asked to join a different study called STARSCAPE 2.
People in the study will be split into two groups. One group will take a medicine called IDRX-42 every day as a white tablet. The other group will take a medicine called sunitinib in a capsule for 4 weeks, then stop for 2 weeks, and keep repeating that schedule. Both medicines are taken by mouth with a glass of water. Before starting, each person will have tests to make sure it is safe for them to join the study.
This study lasts about six months. During the study, participants will give blood samples and have simple energy measurements each month. They will also fill out surveys every month about how they are feeling. In months four and five, participants will take part in a short stress activity. This may include several days of heat exposure, slightly less sleep than usual, or exercise.
This study has five parts: screening, treatment, end of treatment, safety check, and long-term follow-up. - Part A: People will try different amounts of a new medicine called KTX-2001 to find the safest dose. - Part B: People will take the best dose of KTX-2001 along with another medicine called darolutamide. KTX-2001 is taken on an empty stomach. Darolutamide is taken with food twice a day. You will get medicine to take at home and write down when you take it in a diary. You will have regular check-ups, scans, heart tests, and maybe a biopsy. After treatment, doctors will check on you for safety and follow up every few months until your cancer gets worse or you start a new treatment.
We are doing this study to learn more about how environmental contaminants (e.g., "forever chemicals") can affect people's likelihood of developing liver disease.