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

Inclusion Criteria

• Disease that is unresectable, locally advanced, or metastatic (not amendable to curative therapy)
• Understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation
• Life expectancy of at least 3 months in the opinion of the investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Age ≥ 18 years at the time the ICF is signed
• In sexually active patients (women of childbearing potential and males), willingness to use 2 effective methods of contraception, of which 1 must be a physical barrier method (condom, diaphragm, or cervical/vault cap) until 6 months after the last dose of FPA144. Other effective forms of contraception include:
• Permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to Screening
• Women of childbearing potential who are on stable oral contraceptive therapy or intrauterine or implant device for at least 90 days prior to the study, or abstain from sexual intercourse as a way of living
• Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:

Bone Marrow Function

• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
• Platelets ≥ 100 × 10^9/L
• Hemoglobin ≥ 9 g/dL

Hepatic Function

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) CTCAE Grade 1 (with the exception of Grade 2 alopecia)
• Participation in another therapeutic clinical study or receiving any investigational agent within 28 days of enrollment or during this clinical study
• Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other 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) (as defined by a positive immunohistochemistry [IHC] test of 3+ or IHC of 2+ with fluorescent in situ hybridization [FISH])
• Major surgical procedures not permitted ≤ 28 days prior to enrollment. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before enrollment. In all cases the patient must be sufficiently recovered and stable before treatment administration
• Women who are pregnant or breastfeeding (unless the patient is willing to interrupt breastfeeding during study treatment administration and then resume 6 months after study discontinuation); women of childbearing potential must not consider getting pregnant during the study
• Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including arterial thrombosis, or symptomatic pulmonary embolism)
• Presence of any other condition that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry in the study
• Known allergy, hypersensitivity or contraindication to components of the FPA144 formulation including polysorbate or to platinum-containing medications, 5-FU, or leucovorin
• History of prior malignancy, except (Criteria a through f):
• Curatively treated non-melanoma skin malignancy
• Cervical cancer in situ
• Curatively treated Stage I uterine cancer
• Curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy
• Localized prostate cancer that has been treated surgically with curative intent and presumed cured
• Solid tumor treated curatively more than 5 years previously without evidence of recurrence