Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer

Eligibility Criteria

• 1. 1. Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments: Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.
• 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.
• 3. Primary tumors should be amenable to intratumoral (IT) injection \>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.
• 4. Subjects with either a local recurrence or a new primary tumor will be allowed.
• 5. Age ≥ 18 years.
• 6. Have acceptable organ and marrow function defined as follows:
• 7. Ability to understand and the willingness to provide written informed consent.
• 8. Life expectancy \> 12 weeks (about 3 months).
• 9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• 1. Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.
• 2. Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.
• 3. Patients receiving other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) while participating in the study and where all acute toxicity of prior treatments have not resolved.
• 4. Participation in another clinical study with an investigational product during the last 30 days.
• 5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.
• 6. Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
• 7. If applicable: Women who are breastfeeding.
• 8. History of allogenic organ transplant that requires use of immunosuppressives.
• 9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
• 10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
• 11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention.
• 12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.