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Phase I, First In Human Trial Evaluating BI 1387446 Alone And In Combination with BI 754091 in Solid Tumors

Protocol No
BI-1426-0001
Principal Investigator
Jonathan Thompson
Phase
I
Summary
This study will consist of 3 arms, which will recruit patients in parallel with a clear predefined hierarchy for slot allocation (section 3.1.2). Arm A: BI 1387446 as single agent administered intratumorally into superficial lesions. Arm B: BI 1387446 administered intratumorally into superficial lesions, in combination with ezabenlimab (BI 754091) intravenously. Arm C: BI 1387446 administered intratumorally into deep lesions, in combination with ezabenlimab (BI 754091) intravenously.
Description
To characterize the safety and to determine the maximum tolerated dose (MTD) for BI 1387446 in combination with ezabenlimab (BI 754091).
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL