5G-Master and 5G-RUBY
Research type
Research Study
Full title
5G: A Next Generation AGile Genomically Guided Glioma Modular Platform for proof-of-concept molecular hypothesis testing in patients with high grade malignant brain tumours and 5G-RUBY: A Phase 1 /2 trial of the doublet combination of avutometinib and defactinib and as a triplet in combination with temozolomide in patients with high grade malignant brain tumours within the 5G platform
IRAS ID
1007969
Contact name
Juanita Lopez
Contact email
Sponsor organisation
The Institute of Cancer Research
Research summary
Precision medicine (also known as targeted medicine) is a modern approach to treating patients based upon the individual
characteristics of their tumour cells. In this trial, every patient with glioblastoma (GBM), will have their tumour cells analysed by molecular profiling to identify their precise molecular flags. The results of these analyses allow the enrolment of patients with a particular flag/flags onto
a matched novel drug or combination that has been specifically developed to target these aberrations. In other words, the choice of
drug therapy (or treatment) is determined by the characteristics of each patient’s GBM.
This trial uses this precision medicine approach to group patients according to the molecular characteristics of their GBM and test
their matched drug in a three-phase approach. The first phase will establish the best dose to use (Phase 1a), the second phase will
test if the drug shows clinical improvement (Phase 1b) and the third phase will assess the effectiveness of the drug (Phase 2).
The 5G-RUBY clinical study will investigate the combination of experimental medications called defactinib and avutometinib. This is the first time that this combination is given to patients with brain cancer. We want to find out if defactinib and avutometinib work for brain cancers that have molecular flags, or signatures, such as:
1) dependence on RAS-RAF-MEK, a cell pathway in the body that helps cancer cell growth when it is overactive
and
2) loss of Nf1, a protein that protects from cancer cell growth.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0963
Date of REC Opinion
29 Dec 2023
REC opinion
Further Information Favourable Opinion