A Study to Determine How BI 907828 is Taken up in the Tumor and to Determine the Highest Dose of BI 907828 That Could be Tolerated in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma

• Status: Not yet recruiting
• Trial end date: 2027-12-20

Summary

This study is open to adults with newly diagnosed glioblastoma, a type of brain tumor. The study has two parts. Part 1 is open to people who can get their brain tumor removed by surgery. Part 2 is open to people who already had such a brain surgery.

This study tests a medicine called BI 907828. BI 907828 is a so-called Murine double minute 2 (MDM2) inhibitor that is being developed to treat cancer.

The purpose of Part 1 of the study is to find out how BI 907828 is taken up in the tumor. Participants take a single dose of BI 907828 as a tablet before the brain surgery. Part 1 of the study takes about 1 month. During this time, participants have their brain tumor removed by surgery and visit the study site about 8 times.

The purpose of Part 2 is to find the highest dose of BI 907828 that the participants can tolerate in combination with standard radiation therapy. During the first 6 weeks, participants get standard radiation therapy. In addition, they take BI 907828 tablets once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly.

During the entire study, doctors also regularly check participants' health and take note of any unwanted effects.

• Phase: Phase 1

Details

• Lead Sponsor: Boehringer Ingelheim