A Study in People With Advanced Cancer to Test How BI 907828 is Processed in the Body
Status:
Recruiting
Trial end date:
2024-05-10
Target enrollment:
Participant gender:
Summary
This study is open to adults with advanced cancer (solid tumours). People for whom previous
treatment was not successful or no treatment exists can take part. This study tests a
medicine called BI 907828. BI 907828 is a so-called p53-MDM2 antagonist that is being
developed to treat cancer.
The purpose of the study is to find out how BI 907828 is processed in the body. In the first
3 weeks, participants therefore get a single dose of BI 907828 in a labelled form. The first
participants take BI 907828 as a liquid. This is to find out how much BI 907828 is taken up
in the body when it is taken by mouth. Participants who join the study later get BI 907828 as
an infusion into a vein in a labelled form and take BI 907828 as a normal tablet. This is to
find out how long BI 907828 stays in the blood. After the first 3 weeks, all participants
take BI 907828 as tablets every 3 weeks as long as they benefit from treatment and can
tolerate it.
During the study, participants visit the study site regularly. Some of the study visits
include staying overnight. At the beginning, some of the participants stay at the study site
for 15 nights. The doctors also regularly check participants' health and take note of any
unwanted effects.