This study is open to adults with advanced solid tumors whose previous cancer treatment was not successful. People can participate if their tumor has the B7-H6 marker or if they have colorectal cancer. The study tests 2 medicines called BI 765049 and ezabenlimab (BI 754091). Both medicines may help the immune system fight cancer. The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with ezabenlimab the participants can tolerate. In this study, BI 765049 is given to people for the first time. Participants can stay in the study for up to 3 years, if they benefit from treatment and can tolerate it. During this time, they get BI 765049 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. The doctors also regularly monitor the size of the tumor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
BI 765049
ezabenlimab
University of Alabama at Birmingham
Birmingham, Alabama, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
HealthONE
Denver, Colorado, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida, United States
Northwestern University
Chicago, Illinois, United States
Norton Healthcare - Norton Cancer Institute - Louisville
Louisville, Kentucky, United States
New York University Langone Medical Center
New York, New York, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
...and 4 more locations
Maximum tolerated dose (MTD) in any studied regimen
defined as the highest dose with less than 25 percent (%) risk of the true dose limiting toxicity (DLT) rate being equal to or above 33 percent (%) during the MTD evaluation period
Time frame: Up to 3 weeks
Number of patients with dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: Up to 3 weeks
Maximum measured concentration of BI 765049 (Cmax)
Time frame: Up to 36 months
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ)
Time frame: Up to 36 months
Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients with measurable disease
Time frame: Up to 36 months
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