Find and investigate a safe dose of BI 754091 for solid tumours
Research type
Research Study
Full title
An open-label, Phase I trial to determine the maximum-tolerated dose and investigate safety, pharmacokinetics, and efficacy of BI 754091 in patients with advanced solid tumours
IRAS ID
246686
Contact name
Anja Williams
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2017-005043-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
The main objective of the dose-escalation part of the trial is to determine the safety and tolerability, and to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of patients with dose-limiting toxicities (DLTs) in patients with selected advanced solid malignancies. Safety and tolerability will be evaluated by monitoring the occurrence of adverse events (AEs), serious AEs (SAE), and laboratory parameter abnormalities, as well as changes to vital signs.
Secondary objectives are the determination of the Pharmacokinetic (PK) profile of BI 754091 after single and multiple doses of BI 754091, and the preliminary assessment of antitumour activity.
In the dose-expansion part of the trial, the main objectives are to further assess the safety, efficacy, PK profile, and biomarkers of BI 754091 in tumours with specific tumour types and/or genetic mutations at the RP2D.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/1388
Date of REC Opinion
1 Nov 2018
REC opinion
Further Information Favourable Opinion