FRAME: Phase I trial of VS-6063 and RO5126766 (CH5126766)
Research type
Research Study
Full title
FRAME: A Phase I trial of the combination of VS-6063 (FAK inhibitor) and RO5126766 (CH5126766) (a dual RAF/MEK inhibitor) in patients with advanced solid tumours.
IRAS ID
225064
Contact name
Udai Banerji
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2017-001035-39
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The purpose of this study is to find out the side effects and safety of a combination of the FAK inhibitor, VS-6063 and the dual RAF/MEK inhibitor, RO5126766 (also called CH5126766) in patients with advanced solid tumours (enriching for those with RAS mutations) and to determine the most appropriate dose of this combination. During the dose escalation phase, up to 24 patients will be treated with escalating doses of the combination of VS-6063 and RO5126766. Once the dose escalation phase has been completed, the dose with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to the dose expansion phase. The dose expansion phase will evaluate the optimised dose/schedule identified in the dose escalation phase of the study and will be split into two cohorts: one cohort enrolling patients with KRAS mutant non-small-cell lung cancer and one cohort enrolling patients with advanced solid tumours (enriching for those with RAS mutations), who are willing to consent and undergo biopsies at up to three time points.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/1473
Date of REC Opinion
8 Nov 2017
REC opinion
Further Information Favourable Opinion