Debio 1347-201 - The FUZE Clinical Trial
Research type
Research Study
Full title
A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3 "The FUZE Clinical Trial"
IRAS ID
249133
Contact name
Donna Graham
Contact email
Sponsor organisation
Debiopharm International SA
Eudract number
2018-003584-53
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 4 months, 17 days
Research summary
The aim of this study is to evaluate the ability of the investigational drug called Debio 1347 to control and fight cancer cells, so to see if there is a response in terms of tumour reduction, when administered under the recommended dose defined previously in patients with similar types of tumours, where the molecule called FGFR has got a fusion with another molecule and this might be the reason why the cancer has developed.
The study drug Debio 1347 has been designed to block any abnormality of FGFR, including any fusion with other molecules. In doing so, the study drug may help cancer cells to die and therefore shrink the tumour(s). We have some preliminary evidence that Debio 1347 is active against tumours with FGFR fusions, however, more data are necessary to confirm the actual anti-tumour activity of this drug and this is the reason why we are conducting this study.
Approximately 125 patients, 18 years and over, will be recruited in North America, EU, the Middle East, South America and the Asia Pacific region.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0168
Date of REC Opinion
14 Jun 2019
REC opinion
Further Information Favourable Opinion