FIERCE-HN study design

NCT06064877: A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN)

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with R/M human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (R/M HNSCC).

• Multicenter, randomized, double-blind, placebo-controlled Phase 3 study
• Designed to compare the efficacy and safety of two dose levels of ficlatuzumab combined with cetuximab (Arm 1 or Arm 2) to a control arm of placebo plus cetuximab (Arm 3)
  • Ficlatuzumab is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb)
  • Cetuximab is an epidermal growth factor receptor (EGFR) antagonist
• Eligible participants must have failed prior therapy with an anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death ligand 1) immune checkpoint inhibitor (ICI) and with platinum-based chemotherapy, administered in combination or sequentially
• Failure of prior treatment may be due to progression of disease or intolerance to treatment
• Anticipated enrollment: 410 participants