A Study to Test Different Doses of BI 1831169 Alone and in Combination With Ezabenlimab in People With Different Types of Advanced Cancer (Solid Tumors)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This study is for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without ezabenlimab. Another purpose is to see whether BI 1831169 can fight cancer. BI 1831169 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1831169 is given to people for the first time. This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with ezabenlimab. Participants who take the combination treatment get BI 1831169 for up to 3 months and ezabenlimab for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Ezabenlimab is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants\' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by BI 1831169 or ezabenlimab.
Epistemonikos ID: f53a75a8b36da63317820c61dd78f5bf265fb93e
First added on: May 09, 2024