Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

• Status: Not yet recruiting
• Trial end date: 2026-05-11
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.

The main objective Part 2 is to compare efficacy of bemarituzumab plus mFOLFOX6 and nivolumab to placebo plus mFOLFOX6 and nivolumab as assessed by overall survival.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Bemarituzumab; Nivolumab

Criteria

Inclusion Criteria Part 1:

• Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)

• Participant must be a candidate to receive mFOLFOX6 and nivolumab

• Adequate organ function as follows:

• Absolute neutrophil count ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Hemoglobin ≥ 9 g/dl

• Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement). Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement); with the exception of participants with Gilbert's disease)

• Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault

• International Normalized Ratio (INR) or prothrombin time (PT) < 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment.

Additional Inclusion Criteria Part 2:

• No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. Prior adjuvant or neo-adjuvant therapy for localized disease is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment.

• Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by centrally performed immunohistochemistry (IHC) testing

Exclusion Criteria:

• Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway

• Known positive human epidermal growth factor receptor 2 (HER2) status

• Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease

• Peripheral sensory neuropathy grade 2 or higher

• Clinically significant cardiac disease

• Other malignancy within the last 2 years (exceptions for definitively treated disease)

• Chronic or systemic ophthalmologic disorders

• Major surgery or other investigational study within 28 days prior to randomization

• Palliative radiotherapy within 14 days prior to randomization

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

• Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study