A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Bemarituzumab; Placebo; Modified FOLFOX6
Intervention description: Administered by intravenous infusion over approximately 30 minutes; Administered by intravenous infusion over approximately 30 minutes; mFOLFOX6 regimen consists of the following:
Oxaliplatin 85 mg/m² IV infusion over 120 minutes
Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable
5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours
Intervention MeSH terms: Bemarituzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blinded (participant, treating physician)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of the Phase 2 part of the study is to evaluate the efficacy of
      bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to
      placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal
      cancer.
    

Eligibility 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

          -  Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a
             centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification
             as determined by a centrally performed circulating tumor deoxyribonucleic acid (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 human epidermal growth factor receptor 2 (HER2)

          -  Women who are pregnant or breastfeeding

        Note: Other protocol defined Inclusion/Exclusion criteria may apply