Brigimadlin for Solid Cancers

Recruiting at73 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medicine called BI 907828 for adults with advanced cancer in the biliary tract, pancreas, lung, or bladder who have no other treatment options. The medicine is taken as a tablet periodically and works by blocking a protein that helps cancer cells grow.

Research Team

Eligibility Criteria

Adults with advanced biliary tract, pancreatic, lung (adenocarcinoma), or bladder cancer who have tried all other treatments without success or for whom no treatment exists. Participants must have a specific genetic profile (MDM2 amplification and TP53 wild-type) in their tumors, be able to take oral medication every three weeks, and commit to regular health checks at the study site.

Inclusion Criteria

I have advanced lung adenocarcinoma and have tried all standard treatments.

My organs are working well.

I have advanced biliary tract cancer and cannot be treated with surgery or standard treatments.

Exclusion Criteria

I have no health issues that would stop me from following the trial or affect the drug's evaluation.

I have never taken brigimadlin or similar drugs targeting MDM2-p53 or MDMX-p53.

I am currently experiencing bleeding or have a high risk of bleeding.

Treatment Details

Interventions

• BI 907828 (MDM2 Inhibitor)

Trial Overview The trial is testing Brigimadlin (BI 907828), an MDM2 inhibitor taken as a tablet once every three weeks by patients with certain advanced cancers. The goal is to see if it can shrink tumors or stop them from spreading. Patients can continue taking the drug as long as they benefit from it and tolerate its effects.

Participant Groups

Group I: brigimadlin (BI 907828) treatment arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+