Study on NT219 Combined with Standard Biologic Therapy for Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Have incurable head and neck squamous cell carcinoma originating from mucosal areas like the oral cavity, tongue, or throat.
• Have adequate organ and bone marrow function based on routine lab tests.
• Have measurable disease as seen on CT or MRI scans.
• Must have recovered from significant side effects of previous cancer treatments before joining the study.
• For Cohort 1: Must have a tumor with a CPS score greater than 1 and be suitable for pembrolizumab alone, or have benefited from anti-PD-1 therapy before.
• For Cohort 2: Must have cancer that progressed after PD-1 inhibitors or be suitable for cetuximab alone.

Exclusion Criteria

• Cancer of unknown origin or EBV-driven nasopharyngeal cancer.
• Have had four or more lines of treatment for relapsed/metastatic cancer.
• Pregnant or breastfeeding women, or those not using effective birth control.
• Have untreated or unstable brain metastases.
• Have had major surgery within 4 weeks or minor surgery within 1 week before starting treatment.
• Have active HIV infection unless well-controlled.
• Have active hepatitis B or C infections not adequately treated.
• Have received certain cancer treatments or vaccines recently.
• Have had a serious infection or organ transplant recently.
• Have another cancer diagnosed or treated within the last 2 years, except for certain skin cancers.
• For Cohort 1: Have active autoimmune disease needing treatment in the past 2 years.
• For Cohort 2: Have had recent severe heart problems or strokes.