This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time. Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks. Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
BI 1703880
Ezabenlimab
Valkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGJohn Theurer Cancer Center
Hackensack, New Jersey, United States
RECRUITINGNational Cancer Center Hospital East
Chiba, Kashiwa, Japan
RECRUITINGSaitama Medical University International Medical Center
Saitama, Hidaka, Japan
RECRUITINGJapanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGCIO Clara Campal
Madrid, Spain
RECRUITINGInstituto Valenciano de Oncología
Valencia, Spain
RECRUITINGHospital Clinico Universitario de Valencia
Valencia, Spain
RECRUITING...and 3 more locations
Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period
Time frame: up to 6 weeks
Occurrence of DLTs during the on-treatment period
Time frame: up to 804 days
Maximum measured concentration of BI 1703880 in plasma (Cmax)
Time frame: up to 804 days
Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 804 days
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