Full title: A Phase Ia/Ib, Open Label, Dose-escalation Study of the Combination of BI 907828 With BI 754091 (Ezabenlimab) and BI 754111 and the Combination of BI 907828 With BI 754091(Ezabenlimab) Followed by Expansion Cohorts, in Patients With Advanced Solid Tumors
Locations: Royal Marsden Hospital, Velindre Cancer Centre
This study has 2 parts. The first part is 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 BI 907828 and ezabenlimab (also called BI 754091). BI 907828 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 is to find out the highest dose of BI 907828 that the participants can tolerate in combination with ezabenlimab. Once the best dose of BI 907828 for the combination with ezabenlimab is found, it will be used in the second part of the study.
The purpose of the second part is to see whether the combination of BI 907828 with ezabenlimab is able to make tumors shrink.
The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of ezabenlimab, and take tablets with BI 907828 every 3 weeks. The doctors check how many participants have health problems during the study. The doctors also monitor the size of the tumour.