Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

In brief

The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

Key facts

Study ID

NCT05052801

Run by

Amgen

People needed

547

Starts

2022-03-07

Expected to finish

2026-04-26

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
• Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
• Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
• Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
• Participant has no contraindications to mFOLFOX6 chemotherapy
• Adequate organ and bone marrow function:
• absolute neutrophil count greater than or equal to 1.5 times 10\^9/L
• platelet count greater than or equal to 100 times 10\^9/L
• hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
• calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
• international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment

You may not qualify if…

• Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
• Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
• Known human epidermal growth factor receptor 2 (HER2) positive
• Untreated or symptomatic central nervous system (CNS) disease or brain metastases
• Peripheral sensory neuropathy greater than or equal to Grade 2
• Clinically significant cardiac disease
• Other malignancy within the last 2 years (exceptions for definitively treated disease)
• Chronic or systemic ophthalmological disorders
• Major surgery or other investigational study within 28 days prior to first dose of study treatment
• Palliative radiotherapy within 14 days prior to the first dose of study treatment
• Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• The Oncology Institute Clinical Research — Cerritos, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Saint Francis Medical Group — Indianapolis, Indiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Healthier Hematology and Oncology Excelsior Integrated Medical Group — Brooklyn, New York, United States
• White Plains Hospital Center for Cancer Care — White Plains, New York, United States
• Levine Cancer Institute University — Charlotte, North Carolina, United States
• FirstHealth Cancer Center — Pinehurst, North Carolina, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States
• Medical Oncology Associates, PS — Spokane, Washington, United States
• Instituto Alexander Fleming — CABA, Buenos Aires, Argentina
• Hospital Universitario Fundacion Favaloro — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Sociedad de Beneficencia Hospital Italiano — Córdoba, Córdoba Province, Argentina
• Hospital Privado Universitario de Cordoba — Córdoba, Córdoba Province, Argentina
• Hospital Provincial del Centenario — Rosario, Santa Fe Province, Argentina
• Exelsus Oncologia Clinica — San Miguel de Tucumán, Tucumán Province, Argentina
• Instituto Argentino de Diagnostico y Tratamiento IADT — Buenos Aires, Argentina
• Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
• Liverpool Hospital — Liverpool, New South Wales, Australia
• Alaska Oncology and Hematology — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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