West Cancer Center

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

Site Link

NCT05111626

Malignancy

Gastric, Gastroesophageal, esophageal, stomach, esophagus

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

Bemarituzumab, nivolumab

Drug Class

FGFR2b antibody, PD-1 inhibitor

Brad Somer, MD

Sponsor

Amgen

Phase

Phase 3

Status

Open to Enrollment

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