A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

• Status: Not yet recruiting
• Trial end date: 2025-05-03
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies.

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

Details

• Lead Sponsor: Amgen
• Treatments: Bemarituzumab; Nivolumab

Criteria

Inclusion Criteria:

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

• Confirmed FGFR2b overexpression by immunohistochemistry (IHC) (central testing result).

• Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.

• Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version 1.1

• Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.

• Adequate organ function.

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 of first study treatment dose.

• Palliative radiotherapy within 14 days of first study treatment dose.

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