AV-299-23-301: A Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Subjects with Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma

The main purpose of this study is to investigate the safety, effectiveness, and tolerability (whether side effects can be handled by a participant) of ficlatuzumab at two different doses when given with the established dose of cetuximab. The study will also investigate the pharmacokinetics, pharmacodynamics, and immunogenicity of ficlatuzumab. Pharmacokinetics (also called PK) is how the body absorbs, distributes, and eventually gets rid of a drug. Pharmacodynamics (also called PD) is how a drug affects the body, which is measured using markers in your blood or tumor tissue. Immunogenicity is how the body’s immune system (the body’s natural defense against disease) responds, for example, if it reacts to a drug in the same way it reacts to infections.