What is the STARBORN-1 Study?
STARBORN-1 is a medical research study at children’s hospitals and clinics in the US.
Doctors are studying a potential new medicine for lymphatic malformations.

Who can participate in the STARBORN-1 Study?
About 38 children will be enrolled in the study.
Age
6 months to less than 18 years
Medical condition
LM in the head, neck, or area of the chest between the lungs
A few facts about lymphatic malformations (LMs)
- LMs are fluid-filled spaces that are part of the lymphatic system.
- The lymphatic system helps protect you from infection and keeps a healthy balance of fluids in the body.
- LMs prevent lymph fluid from draining properly, which can affect a child’s health and appearance.
- LMs can form anywhere on the body and are most often seen in the head and neck area.

What happens during the STARBORN-1 Study?
Your child will be in the study for up to 54 weeks and will have to visit the hospital/clinic approximately 8 times.
Your child will receive up to 4 doses of the study medicine. Each dose will be about 6 weeks apart.
After this, your study doctor may discuss additional doses with you if they think your child could possibly benefit.
Hover over each pin for visit details.



What is the study medicine?
The study medicine is injected into a target cyst in the LM. It is designed to start an immune response that shrinks the target cyst.
The study medicine is similar to a medicine that has been used in other countries to treat LMs and other conditions for over 20 years. Children participating in this study will be some of the first children in the United States to receive the study medicine to treat LMs.
The study medicine is not yet approved by the United States Food & Drug Administration (FDA).
What kinds of tests and procedures will there be?
Your child’s well-being is the number one priority. The study doctor will regularly check your child’s health for safety and to see how well the study medicine works.

Health review

Physical exam

Heart test

Imaging

Ultrasound

Blood tests

Questionnaires

Study medicine injection

Participant Diary
For 14 days after each injection, you’ll use an app to report your child’s temperature and any reactions or side effects. You can use your own electronic device or the study team will provide you with one. They will show you how to use the app.
Ready to get started?
Ask your child's pediatrician or LM specialist about the STARBORN-1 Study. They can help connect you with a study doctor.
Visit ClinicalTrials.org to see a list of participating hospitals/clinics. Trial ID# NCT05871970