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GASTRIC: 1st Line: FGFR2b overexpression: FORTITUDE-102

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

Title
Amgen 20210098 FORTITUDE 102 Gastric FGFR2b
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

Site Link
Malignancy
Gastric, Gastroesophageal, esophageal, stomach, esophagus
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Bemarituzumab, nivolumab
Drug Class
FGFR2b antibody, PD-1 inhibitor
PI
Brad Somer, MD
Sponsor
Amgen
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Unresectable, locally advanced, or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive by centrally performed IHC testing
  • No prior therapy for metastatic or unresectable disease except for up to 1 dose FOLFOX with or withouy nivolumab. Prior adjuvant therapy allowed as long as completed longer than 6 months prior
  • ECOG PS 0-1
  • Measurable or non-measurable disease allowed
  • No symptomatic CNS mets
  • No corneal abnormalities
  • No known HER2 positive status
  • No peripheral sensory neuropathy grade 2 or higher
Objective
  • Primary
    • Overall survival
  • Secondary
    • ORR
    • DoR
    • DCR
    • PFS
    • Safety
    • QOL
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X