Sponsor: Amgen, Inc.
Sponsor Study ID: 20210098
Study Title: A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE 102)
CTO #: 103514
NCT Number: NCT05111626
Phase: I
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Esophagus; Stomach
Study Objectives: This is a double-blind, randomized, placebo-controlled multicenter Phase 1b/3 study to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of bemarituzumab + mFOLFOX6 + nivolumab versus placebo + mFOLFOX6+ nivolumab in subjects with advanced gastric or gastroesophageal junction adenocarcinoma that express FGFR2b and who have not received prior treatment for unresectable or metastatic disease.