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Brief Title: A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors)
Official Title: An Open Label, Phase I Study of BI 765063 Monotherapy, and Its Combination Therapy With BI 754091, to Characterize Safety, Pharmacokinetics, and Pharmacodynamics in Japanese Patients With Advanced Solid Tumors
Study ID: NCT04653142
Brief Summary: 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.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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