A Study Evaluating Bemarituzumab in Solid Tumours with FGFR2b Overexpression
Research type
Research Study
Full title
A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE 301)
IRAS ID
1005021
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen, Inc.
Eudract number
2021-006386-38
Clinicaltrials.gov Identifier
Research summary
Fibroblast growth factor 2b (FGFR2b) is a receptor on the surface of cancer tumour cells that plays an important role in tumour cell growth and survival. In a substantial number of people the tumour produces more than normal amounts of this receptor (overexpression) and this has been linked to significantly worse survival compared with tumours that do not overexpress. \n\nBemarituzumab is an antibody that acts specifically on the FGFR2b receptor and works in two ways. First, it binds to the FGFR2b receptors in place of the fibroblast growth factors to prevent tumour growth. Second, it attracts natural killer cells, a type of white blood cell which is part of the body’s immune system, to help kill the tumour cell. \n\nSeveral different types of cancer have been reported to produce more of the FGFR2b receptor than normal and this study aims to evaluate if Bemarituzumab will have an effect in reducing tumours of the head and neck, triple-negative breast cancer, cancers of the pancreas, liver and colon/rectum and gynaecological cancers. \n\nThe treatment will be given on its own by infusion. \n\nBetween 360 and 375 people will take part in the study globally. The study duration will consist of a screening period of up to 28 days, a variable period on treatment with cycles of chemotherapy every 14 days, a safety follow up 28 days after last dose of study product and then a long-term follow up period with calls every 3 months.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0095
Date of REC Opinion
1 Jul 2022
REC opinion
Further Information Favourable Opinion