Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC

Exclusion Criteria

• •1. Pregnant, lactating, or planning to become pregnant.
• •2. Presence of known or suspected systemic cancer.
• •3. Confirmatory histological report of the qualified isSCC lesion reveals evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the opinion of the investigator.
• •4. History of recurrence of the target isSCC lesion.
• •5. Concurrent disease or treatment that suppresses the immune system.
• •6. Subjects with baseline QT corrected interval QTc \> 480 msec using Fridericia's formula.
• •7. Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk.
• •8. Known sensitivity to any of the ingredients in the study medication including an allergy to trehalose.
• •9. Use of a tanning bed or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the study.
• •10. Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit.
• •11. Use of systemic retinoids within the 6 months prior to the screening period.
• •12. Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period.
• •13. Use of topical immunomodulators within 2 cm of the target isSCC lesion within the 4 weeks prior to the screening period.
• •14. Treatment with the following topical agents within 2 cm of the target isSCC lesion within the 4 weeks prior to the screening visit: aminolevulinic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.
• •15. Treatment with liquid nitrogen, surgical excision, or curettage within 2 cm of the target isSCC lesion during the 4 weeks prior to the screening visit.
• •16. Evidence of current chronic alcohol or drug abuse that, in the opinion of the investigator, would impair the subject's ability to comply with study schedule.
• •17. Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit.
• •18. In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.