Brightline-2: Testing Brigimadlin (BI 907828) for Cancer in the Biliary Tract, Pancreas, Lung, or Bladder

Sponsor: Boehringer Ingelheim

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05512377

Provider View

This study is for adults with advanced cancer in the biliary tract, pancreas, lung, or bladder, where previous treatments have not worked or no treatments are available. It aims to find out if the drug BI 907828 can help treat these cancers.

Patient Parameters

Program Overview

This clinical trial is for adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. The study is testing a drug called BI 907828, which is a type of medication known as an MDM2 inhibitor, designed to treat cancer. Participants will take BI 907828 as a tablet once every three weeks. They can continue taking the drug as long as it is beneficial and they can tolerate it. Regular visits to the study site are required, where doctors will check the size of the tumor and whether it has spread, as well as monitor the participant's health and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Have a diagnosis of a solid tumor in one of the following categories:
    • Biliary tract cancer: Advanced or metastatic cancer in the bile ducts, gallbladder, or ampulla. The cancer cannot be removed by surgery, and all standard treatments have been tried or are not suitable.
    • Pancreatic cancer: Advanced or metastatic pancreatic cancer that cannot be surgically removed, with all standard treatments tried.
    • Lung cancer: Advanced or metastatic lung cancer that cannot be surgically removed, with all standard treatments tried.
    • Bladder cancer: Advanced or metastatic bladder cancer that cannot be surgically removed, with all standard treatments tried.
  • Have a report showing MDM2 amplification or a high copy number and normal TP53 status, confirmed by a tissue test.
  • Provide a previous tumor sample for confirmation of MDM2 and TP53 status.
  • Have at least one measurable tumor according to specific criteria.
  • Be in good general health with an ECOG performance status of 0 or 1.
  • Be willing to provide blood samples for study analysis.
  • Have adequate organ function.
  • Have resolved any side effects from previous cancer treatments to a mild level, except for hair loss or menstrual issues, which can be any level, and mild nerve damage.
  • Have a life expectancy of at least 3 months.
  • Provide signed informed consent.
  • Be 18 years or older.
  • Agree to use effective birth control during the study and for a specified time after the last dose.

Exclusion Criteria

  • Have previously taken BI 907828 or similar drugs.
  • Have active bleeding or a high risk of bleeding.
  • Have had major surgery recently or plan to have major surgery soon.
  • Have other significant cancers that could affect the study.
  • Need to take medications that could interfere with the study.
  • Are currently in another clinical trial.
  • Have any condition that could affect participation or the study's results.
  • Are not expected to follow the study requirements or complete the study due to issues like substance abuse.

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