A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)
- Conditions
- Gastric and Gastroesophageal Cancer
- Registration Number
- JPRN-jRCT2080224734
- Lead Sponsor
- Five Prime Therapeutics, Inc. (ICCC: ICON JAPAN K.K.)
- Brief Summary
Overall, the results of final analysis phase 2 study suggest that 15 mg/kg bemarituzumab administered Q2W as a 30-minute infusion and a single dose of 7.5 mg/kg on day 8 of cycle 1 in combination with mFOLFOX6 demonstrated an acceptable safety profile and evidence of clinical response for FGFR2b positive selected subjects with previously untreated gastric and GEJ adenocarcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 155
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method