At a glance
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An Open Label, Phase I Dose-finding Study of BI 754111 in Combination With BI 754091 in Patients With Advanced Solid Cancers Followed by Expansion Cohorts at the Selected Dose of the Combination in Patients With Non-small Cell Lung Cancer and Other Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Ezabenlimab and BI 754111 for Neoplasms and Carcinoma, Non-Small-Cell Lung. Completed, enrolled 172 participants across 15 sites in 5 countries.
Detailed Summary
This is a study in adults with advanced solid tumors including non-small cell lung cancer. The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer. Such medicines are called immune checkpoint inhibitors. The study has two parts. In the first part, doctors want to find out the highest dose of 2 medicines that people with solid tumors can tolerate. This dose is then used for the second part of the study. In the second part, the combination of the two medicines is tested in patients with non-small cell lung cancer and other types of solid cancer. These patients had gotten treatment with anti-PD-1 or anti-PD-L1 medicines but their tumors have come back. The doctors check whether the combination of BI 754111 and BI 754091 makes tumors shrink. Both medicines are given as an infusion into the vein every 3 weeks. If there is benefit for the patients and if they can tolerate it, the treatment is given for maximum of 1 year. During the entire study doctors will regularly check the health of the patients.
Study Details
Timeline
Interventions
240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w)
Different dosages of BI 754111 given as an intravenous infusion on day 1 of 21-day cycles (q3w).