* BI 1823911 in advanced or metastatic tumours 1472-0001
Research type
Research Study
Full title
A Phase Ia/Ib, open-label, multicentre dose-escalation and expansion study to investigate the safety, pharmacokinetics and preliminary efficacy of BI 1823911 as a monotherapy and in combination with other anti-cancer therapies in patients with advanced or metastatic solid tumours expressing KRAS G12C mutation
IRAS ID
303047
Contact name
Colin Lindsay
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2021-000460-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 2 months, 0 days
Research summary
This first in human trial includes two different treatment regimens. BI 1823911 (investigational drug) administered alone will be investigated in Arm 1, also called the monotherapy arm. BI 1823911 combined with BI 1701963 will be investigated in Arm 2, also called the combination therapy arm.
The trial will invite participation from patients with advanced cancer, in particular a solid tumour with a KRAS G12C mutation, that worsened during or after standard therapy, or for which no effective standard therapy is available.
It is planned to take place within the NHS in the UK. The length of participation and number of visits will depend on whether participants are benefiting from the trial medication. If participants benefit, they may continue taking BI 1823911 for as long as this is the case.
The trial purpose is to test the safety of BI 1823911 as well as test different doses to see which doses have less unacceptable side effects and are more effective in patients with solid tumours that harbour a KRAS G12C mutation. The trial will also look at how the BI 1823911 is used by the body and how fast or slow it moves through or out of the body, as well as testing the effects of other drugs and food on the investigational medicine (only in the monotherapy arm). The information will support evaluation of recommended doses for future trials.
REC name
London - South East Research Ethics Committee
REC reference
21/FT/0118
Date of REC Opinion
14 Oct 2021
REC opinion
Further Information Favourable Opinion