進行癌（固形腫瘍）の異なる種類の患者を対象に、BI 907828（ブリギマドリン）とBI 754091（エザベンリマブ）およびBI 754111の異なる用量、またはBI 907828（ブリギマドリン）とBI 754091（エザベンリマブ）の併用を試験する研究

基本情報

NCT ID

NCT03964233

ステータス

完了

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

119

治験依頼者名

Boehringer Ingelheim

概要

This study has 2 parts. The first part of the study is done. The first part was open to adults with different types of advanced cancer (solid tumors). The second part is open to people with specific types of soft tissue sarcoma, advanced lung cancer, and cancer in the stomach, bladder or bile ducts. The participants get a combination of 2 medicines called brigimadlin (also called BI 907828) and ezabenlimab (also called BI 754091). Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor). When the study started, some participants got a third medicine called BI 754111 in addition. Treatment with BI 754111 was stopped because data from another study showed no additional effect of BI 754111. The purpose of the first part of the study was to find out the highest dose of brigimadlin that the participants could tolerate in combination with ezabenlimab. This dose is used in the second part of the study. The purpose of the second part is to see whether the combination of brigimadlin with ezabenlimab is able to make tumors shrink. The participants are in the study as long as they benefit from treatment and can tolerate it. Ezabenlimab treatment is limited to 2 years. During this time, they get infusions of ezabenlimab, and take tablets with brigimadlin every 3 weeks. The doctors check how many participants have health problems during the study. The doctors also monitor the size of the tumor.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)