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
309762
Contact name
Kathrina Alexander
Contact email
Sponsor organisation
Roche Diagnostics Solutions
Clinicaltrials.gov Identifier
2021-003477-61, EudraCT number (Amgen's Clinical Study 20210098)
Duration of Study in the UK
2 years, 8 months, 0 days
Research summary
Amgen study FORTITUDE-102 is a clinical trial to evaluate the safety and efficacy of an investigational medicinal product (bemarituzumab) for advanced gastric cancer, with one test site located in the United Kingdom. Approximately 4200 patients will be screened globally with the goal of including approximately 682 patients in the trial.
A new test (assay) is being used to help select the patients who will be included in this study. The investigational medicine being studied, bemarituzumab, targets a protein called fibroblast growth factor receptor 2b (FGFR2b). 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. Therefore, a novel immunohistochemistry (IHC) assay, which measures the expression of FGFR2b protein in tumor tissue sections, has been developed for this purpose and will be used to aid in patient selection for the Amgen FORTITUDE-102 study. Tumor specimens stained and tested with the assay will be reviewed by qualified pathologists who will assign an FGFR2b IHC status of positive or negative. If a patient’s status is considered FGFR2b-positive they will be potentially eligible for the study.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0276
Date of REC Opinion
27 Apr 2022
REC opinion
Unfavourable Opinion