267 Participants Needed

BI 907828 for Advanced Cancer

Recruiting at 32 trial locations
BI
AU
Overseen ByAdditional US locations available on demand. Please contact for options.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

No standard treatments are suitable or available for my condition.
I have NSCLC, urothelial, gastric, biliary tract, or pancreatic cancer with specific genetic features and have received at least one treatment for advanced disease.
My cancer can be measured by tests or seen on scans.
See 11 more

Exclusion Criteria

I have a history of unusual bleeding or clotting.
I have not taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.
My tumor has a TP53 mutation.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of brigimadlin to determine the most suitable dose

Varies
Regular health checks

Dose Expansion

Participants receive the most suitable dose of brigimadlin to assess tumor response

Varies
Regular health checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BI 907828
Trial OverviewThe trial is testing the safety and effectiveness of a new cancer drug called BI 907828 (brigimadlin), an MDM2 inhibitor taken as a tablet. It aims to determine the best dose that shrinks tumors, given either once every three weeks or twice every four weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Group II: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+