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

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Bemarituzumab

Criteria

Inclusion Criteria:

• Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy

• Confirmed fibroblast growth factor receptor 2b (FGFR2b) overexpression by immunohistochemistry (IHC) (central testing result)

• Eastern Cooperative Oncology Group (ECOG) less than or equal to 1

• Measurable, evaluable, or non-evaluable disease as long as evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) version 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 greater than or equal to 9 g/dl

• 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 greater than or equal to 30 mL/minute calculated using the formula of Cockcroft and Gault

• 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

Exclusion Criteria:

• Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose)

• 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

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