This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
Film-coated tablet
Sarcoma Oncology Center
Santa Monica, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States
START Midwest
Grand Rapids, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Cliniques Universitaires Saint-Luc
Brussels, Belgium
...and 17 more locations
Phase Ia- Maximum tolerated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycle
Time frame: Up to 28 days
Phase Ib - Progression-free survival
Time frame: Up to 24 months
Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)
Time frame: Up to 28 days
Phase Ib - Number of patients with DLTs during the first treatment cycle
Time frame: Up to 28 days
Phase Ia - Cmax: Maximum measured concentration of BI 907828 in plasma
Time frame: Up to 24 months
Phase Ia - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
Time frame: Up to 24 months
Phase Ib - Objective response
Time frame: Up to 24 months
Phase Ib - Overall survival
Time frame: Up to 24 months
Phase Ib - Number of patients with Grade ≥3 treatment-related adverse events observed during the entire treatment period
Time frame: Up to 24 months
Phase Ib - Cmax: Maximum measured concentration of BI 907828 in plasma
Time frame: Up to 24 months
Phase Ib - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
Time frame: Up to 24 months
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