Brightline-2: A Phase IIa/IIb open-label single-arm multi-centre trial of brigimadlin (BI 907828) for treatment of patients with locally advanced / metastatic MDM2 amplified TP53 wild-type biliary tract adenocarcinoma pancreatic ductal adenocarcinoma or other selected solid tumours
Brief description of study
The purpose of the trial is to study a drug called BI 907828 for the treatment of certain types of advanced or spreading tumors. These tumors have a genetic abnormality called MDM2 amplification and a normal TP53 gene. These tumors cannot be effectively treated with targeted therapies or standard treatments. Currently, there are limited treatment options available for these patients, and the available chemotherapies have limited effectiveness and may not be suitable for many patients. BI 907828 is a drug that can be taken orally and works by blocking the interaction between MDM2 and p53, which is believed to be beneficial in treating these tumors. The trial aims to provide a new treatment option quickly for patients with a high medical need that is currently unmet.
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