Study of BI 754111 combined with BI 754091 for advanced solid cancers
Research type
Research Study
Full title
An open label, Phase I dose-finding study of BI 754111 in combination with BI 754091 in patients with advanced solid cancers followed by expansion cohorts at the selected dose of the combination in patients with non-small cell lung cancer and other solid tumors
IRAS ID
253523
Contact name
Anja Williams
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2017-005042-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 1 days
Research summary
This study will test the investigational drug, BI 754111 (study drug), for the first time. BI 754111 will be tested by itself and in combination with another investigational study drug, BI 754091. It is thought that by combining the 2 study drugs, they may have more of an effect on cancer cells rather than if they were used alone.
This is a two part study. The main purpose of both parts of the study is to investigate the safety and tolerability of the study drugs in humans. The second part (Part II) of the study will also investigate whether the study drugs have any effect on tumour growth. Sites in the UK will only participate in Part II, Dose Expansion. Levels of the study drugs in patient's blood will be measured to see how the body accepts and gets rid of them. Samples of their blood and tumour tissue will be taken to examine for possible cancer markers. Tumour tissue will only be taken from subjects in Part II.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0677
Date of REC Opinion
4 Feb 2019
REC opinion
Further Information Favourable Opinion