BI 907828 (Brigimadlin)
DrugBI 907828 (Brigimadlin)
Other names: Brigimadlin
NCT Number: NCT05376800
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 (Brigimadlin). BI 907828 (Brigimadlin) is a socalled MDM2 inhibitor that is being developed to treat cancer.
The purpose of Part 1 of the study is to find out how BI 907828 (Brigimadlin) is taken up in the tumor. Participants take a single dose of BI 907828 (Brigimadlin) 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 (Brigimadlin) 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 a dose of BI 907828 (Brigimadlin) once every 3 weeks. Participants may continue to take BI 907828 (Brigimadlin) 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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
UZ Leuven, Leuven, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Further inclusion criteria applies.
Exclusion criteria
BI 907828 (Brigimadlin)
Other names: Brigimadlin
Time frame: Up to 24 hours (h)
Brain tissue samples will be collected after standard of care neurosurgical tumor resection.
Concentration of BI 907828 (Brigimadlin) will be quantitated in nanomole/kilogram (nmol/Kg) of tissue by validated liquid chromatography mass spectrometry (LC/MS) method.
Time frame: Up to 24 hours (h)
Brain tissue samples will be collected after standard of care neurosurgical tumor resection.
Concentration of BI 907828 (Brigimadlin) will be quantitated in nanomole/kilogram (nmol/Kg) of tissue by validated liquid chromatography mass spectrometry (LC/MS) method.
Time frame: Up to 63 Days
Time frame: Up to 7 months.
Time frame: Up to 24 hours (h)
Time frame: Up to 8 months.
Time frame: Up to Day 17
Time frame: Up to Day 17
Time frame: Up to Day 17
Boehringer Ingelheim
Industry
A Phase 0/Ia Study of BI 907828 (Brigimadlin) Concentrations in Brain Tissue and a Non-randomized Open-label, Dose Escalation Study of BI 907828 (Brigimadlin) in Combination With Radiotherapy in Patients With Newly Diagnosed Glioblastoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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