BI 907828 for Advanced Cancer
Trial Summary
What is the purpose of this trial?
This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that patients who need to continue restricted medications or drugs that might interfere with the trial cannot participate. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
Adults with various advanced solid tumors who have progressed after prior treatments or have no standard treatment options can join. They must be willing to provide tissue samples and undergo regular health checks. Those with specific genetic tumor profiles (TP53 wild type, MDM2-amplified) are eligible for certain study phases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of brigimadlin to determine the most suitable dose
Dose Expansion
Participants receive the most suitable dose of brigimadlin to assess tumor response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BI 907828
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor