Brigimadlin for Solid Cancers

Recruiting at 74 trial locations

Overseen By Additional US locations available on demand. Please contact for options.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: MDM2-p53 antagonists

Disqualifiers: Active bleeding, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 months

99 Participants Needed

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking any medications that might interfere with the trial, you may need to stop them. It's best to discuss your specific medications with the trial 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take BI 907828 as a tablet once every 3 weeks. Regular visits to the study site for health checks and monitoring of tumour size and spread.

Up to 30 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• BI 907828

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+