Phase 3 Study Comparing Petosemtamab with Other Treatments for Previously Treated Head and Neck Cancer

Inclusion Criteria

• Must sign a consent form before starting any study procedures.
• Must be 18 years or older.
• Must have a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) that has spread or is locally advanced and cannot be treated with standard curative therapy.
• Cancer must have progressed after anti-PD-1 therapy and platinum-based chemotherapy.
• Eligible primary tumor locations include the oropharynx, oral cavity, hypopharynx, and larynx.
• Must have documentation of p16 status for oropharyngeal cancer.
• Must provide a new tumor sample or have an available tumor sample with enough material.
• Must have measurable disease as defined by specific imaging criteria.
• Must have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have a life expectancy of at least 12 weeks.
• Must have adequate organ function as per study protocol.

Exclusion Criteria

• Untreated or symptomatic brain metastases, or those requiring recent treatment to control symptoms.
• Known cancer spread to the membranes covering the brain and spinal cord.
• Any cancer treatment within 4 weeks before starting the study treatment.
• Major surgery or radiation within 3 weeks before starting the study treatment.
• Ongoing significant side effects from previous cancer treatments.
• Allergic reactions to any components of the study treatment.
• Unstable heart conditions or recent heart attack.
• History of other cancers, except for certain low-risk types.
• Difficulty breathing at rest or need for continuous oxygen therapy.
• Serious ongoing illnesses or medical conditions, including uncontrolled infections or significant lung, metabolic, or psychiatric disorders.
• Known infectious diseases as per study protocol.
• Pregnant or breastfeeding women.
• Primary tumor located in the nasopharynx.