A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

• Status: Active, not recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Five Prime Therapeutics, Inc.
• Collaborator: Zai Lab (Shanghai) Co., Ltd.
• Treatments: Bemarituzumab

Criteria

Key Inclusion Criteria:

• Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1

• FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay

• Candidate for mFOLFOX6 chemotherapy

Key Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases

• Clinically significant cardiac disease,

• Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2

• Active infection requiring systemic treatment

• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection

• Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway

• Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer

• Known positivity for HER2

• Women who are pregnant or breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply