This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study. The purpose of this study is to find the highest dose of BI 770371 that people with advanced cancer can tolerate when taken alone or together with a medicine called ezabenlimab. BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer (checkpoint inhibitors). In this study, BI 770371 is given to people for the first time. Participants get BI 770371 alone or together with ezabenlimab as an infusion every 3 weeks. It is planned that participants can stay in the study for up to 2 years, if they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. The doctors collect information on any health problems of the participants. The doctors also regularly monitor the size of the tumour.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
BI 770371
ezabenlimab
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in monotherapy
Time frame: 21 days
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in combination therapy
Time frame: 21 days
Occurrence of Adverse Events (AEs) during the on-treatment period in monotherapy
Time frame: up to 2 years
Occurrence of Adverse Events (AEs) during the on-treatment period in combination therapy
Time frame: up to 2 years
Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in monotherapy
Time frame: up to 2 years
Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in combination therapy
Time frame: up to 2 years
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