BI 894999 First in Human Dose Finding Study in Advanced Malignancies

Summary

This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful. In some countries, adolescents who are at least 15 years old and who are diagnosed with NUT carcinoma can also participate. No standard treatment exists for this rare and aggressive form of cancer. The purpose of this study is to find out the highest dose of BI 894999 that people can tolerate. BI 894999 is tested for the first time in humans. Participants take tablets once daily. The study also tests whether participants can tolerate BI 894999 better when taken continuously or with breaks in between. Participants can stay in the study as long as they benefit from the treatment and can tolerate it. The doctors also regularly check the general health of the participants.

Timeline

Start

2015-07-08

Primary completion

2021-11-23

Completion

2021-11-23

Publications

• Schoffski P, Machiels JP, Rottey S, Sadrolhefazi B, Musa H, Marzin K, Awada A. Phase Ia dose-escalation trial with the BET protein inhibitor BI 894999 in patients with advanced or metastatic solid tumours. Eur J Cancer. 2023 Sep;191:112987. doi: 10.1016/j.ejca.2023.112987. Epub 2023 Jul 11.

Drugs

Indications