IFx-Hu2.0 for the Treatment of Patients With Skin Cancer

Inclusion Criteria

• •1. Provision of signed and dated informed consent form
• •2. Stated willingness to comply with all study procedures and availability for the duration of the study
• •3. Ability to receive intralesional injections
• •4. Male or female, aged ≥ 18 years
• •5. Histologically confirmed cutaneous squamous cell carcinoma, or basal cell carcinoma with accessible lesions (based on archival tissue or new tissue biopsy for histological confirmation)
• •6. Life expectancy of at least 24 weeks at the time of screening
• •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• •8. Must have measurable disease greater than 3 mm
• •9. At least one injectable lesion
• •10. Adequate organ function as defined below (Note: these screening laboratory tests must be obtained within two weeks prior to the baseline visit, Day 0):
• •10.1. Hemoglobin (Hb) \>10 g/dL 10.2. Absolute Neutrophil Count (ANC) \>1,500 cells/mcL 10.3. Platelet Count (PLT) \>75,000/mcL 10.4. Prothrombin Time (PT) or International Normalized Ratio (INR) ≤1.5 times the institutional ULN unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of the intended use of anticoagulants.
• •10.5. Activated Partial Thromboplastin Time (aPTT) ≤1.5 times the institutional ULN unless patient is receiving anticoagulant therapy as long as aPTT is within therapeutic range of the intended use of anticoagulants.
• •10.6. Serum Creatinine (SCr) ≤1.5 times the institutional ULN 10.7. Total Bilirubin ≤1.5 times the institutional ULN 10.8. Aspartate Aminotransferase (AST) ≤3 times the institutional ULN 10.9. Alanine Aminotransferase (ALT) ≤3 times the institutional ULN 10.10. Lactate Dehydrogenase (LDH) ≤2 times the institutional ULN 10.11. Alkaline Phosphatase (ALP) ≤2.5 times the institutional ULN 10.12. Gamma GT (GGT) ≤2.5 times the institutional ULN
• •11. Lymphocyte count ≥500,000 cells/mL
• •12. For females of reproductive potential: must have a negative urine or serum pregnancy test result within 24 hours prior to receiving IFx-Hu2.0; must use highly effective contraception (e.g.,licensed hormonal or barrier methods) for at least one month prior to screening and agreement to use such a method during study participation and for an additional 26 weeks after the end of study treatment
• •13. For males of reproductive potential: use of barrier method or other methods to ensure effective contraception with partner