A Phase 2 Study of BI 907828 in People With Biliary Tract Cancer, Pancreatic Cancer, and Other Solid Tumors

Full Title

Brightline-2: A Phase IIa/IIb, Open-Label, Single-Arm, Multi-Centre Trial of 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

Purpose

Researchers want to see how well BI 907828 works in people with advanced cancer. The people in this study have pancreatic, biliary, or other solid cancers that have metastasized (spread). In addition, their tumors contain a mutation (change or variant) in a gene called MDM2 and a normal TP53 gene.

When cancer has an MDM2 mutation, the MDM2 protein made by this gene interacts with the TP53 protein. This interaction allows cancer cells to grow. BI 907828 blocks the interaction between the MDM2 and TP53 proteins. This action may stop cancer cells from growing or kill them. BI 907828 is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

• Have metastatic pancreatic or biliary cancer or another solid tumor.
• Have cancer that has an MDM2 mutation but normal TP53.
• Have recovered from the serious side effects of previous treatments.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. James Harding’s office at 646-888-4314.