VENTANA FGFR2b (FPR2-D) - FORTITUDE-102
Research type
Research Study
Full title
Diagnostic Protocol for VENTANA FGFR2b (FPR2-D) RxDx Assay in Amgen Study 20210098
IRAS ID
317373
Contact name
Kathrina Alexander
Contact email
Sponsor organisation
Roche Diagnostics Solutions
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2021-003477-61, EudraCT number (Amgen's Clinical Study 20210098)
Duration of Study in the UK
3 years, 9 months, 25 days
Research summary
This study is being conducted to demonstrate clinical performance of the VENTANA FGFR2b RxDx Assay to identify patients with fibroblast growth factor receptor 2b (FGFR2b) positive expression status by testing tumor tissue biopsy samples from patients with Gastric cancer (GC) and GEJ cancer.
The study is sponsored by Roche Tissue Diagnostics and the primary objective is to utilize the clinical study assay as a screening test in Phase 3 of Amgen’s Clinical Study Protocol 20210098.
It is estimated that approximately 4200 patient tissue biopsy samples will be screened globally with the goal of including approximately 682 patients into Amgen’s 20210098 trial. The expected enrolment period is approximately 3 years and 9 months (planned start date: 18-Jul-2022, planned end date: 11-May-2026), which is therefore also the expected duration of this clinical performance study.The testing with the VENTANA FGFR2b RxDx Assay of the samples originating from EU, UK, Israel, Turkey and Switzerland will take place at Q2 Solutions, Livingston, Scotland.
FGFR2b is present on a substantial subset of gastric cancers and is a target for new therapies that may improve treatment outcomes.
The investigational medicine being studied in Amgen 20210098 trial, bemarituzumab, targets the FGFR2b protein. Bemarituzumab is an antibody drug which will be used in combination with the routine chemotherapy treatment referred to as mFOLFOX6 and another antibody therapy called nivolumab. Since only a group of patient tumors express FGFR2b protein, it is important to identify those patients. Currently, there is no Health Authority approved assay for FGFR2b.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0124
Date of REC Opinion
31 Aug 2022
REC opinion
Further Information Favourable Opinion