Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck

Major

Inclusion Criteria:

- Male or female patients >18 years of age.

- Patients with documented histologic evidence of head and neck cancer with clinically
measurable disease. Head and neck cancer can be recurrent after primary treatment
with surgery, radiation therapy and/or chemotherapy.

- ECOG Performance Status of 0, 1, or 2.

- Absolute neutrophil 1500/uL, hemoglobin 8 gm %, platelets 50,000/uL,

- ALT/AST < 3 x ULN (upper limit of the normal range), bilirubin < 1.5 x ULN and
creatinine < 1.5 x ULN, PT and PTT within normal limits.