This study is open to Japanese adults with advanced cancer (solid tumors). This is a study in people for whom previous treatment was not successful and for whom no standard therapy exists. The purpose of this study is to find the highest dose of BI 765063 that people can tolerate when taken alone or together with a medicine called BI 754091. BI 765063 and BI 754091 are antibodies that may help the immune system fight cancer (checkpoint inhibitors). Participants get BI 765063 alone or together with BI 754091 as infusion every 3 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors check the health of the participants and note any health problems that could have been caused by BI 765063 or BI 754091.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
BI 765063
BI 754091
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
Shikoku Cancer Center
Ehime, Matsuyama, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan
Maximum Tolerated Dose (MTD) of BI 765063, Part A
Time frame: up to 3 weeks
Maximum Tolerated Dose (MTD) of BI 765063, Part B
Time frame: up to 3 weeks
Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part A
Time frame: up to 3 weeks
Number of patients with dose limiting toxicity (DLT) in the MTD evaluation period, Part B
Time frame: up to 3 weeks
Number of patients with DLTs, Part A
Time frame: 3 weeks per treatment cycle
Number of patients with DLTs, Part B
Time frame: 3 weeks per treatment cycle
Percentage of patients with drug related Adverse Events (AE), Part A
Time frame: 3 weeks per treatment cycle
Percentage of patients with drug related Adverse Events (AE), Part B
Time frame: 3 weeks per treatment cycle
Cmax (maximum concentration) for BI 765063, Part A
Time frame: up to 3 weeks
Cmax (maximum concentration) for BI 765063, Part B
Time frame: up to 3 weeks
Cmax (maximum concentration) for BI 754091, Part B
Time frame: up to 3 weeks
AUC0-tz (area under the curve) for BI 765063, Part A
Time frame: up to 3 weeks
AUC0-tz (area under the curve) for BI 765063, Part B
Time frame: up to 3 weeks
AUC0-tz (area under the curve) for BI 754091, Part B
Time frame: up to 3 weeks
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