Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers

Inclusion Criteria

• •Life expectancy ≥ 3 months at recruitment
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at the time of study treatment initiation.
• •Males or females with histologically confirmed diagnosis of advanced non-melanoma skin cancers.
• •Patients must have progressed despite standard therapy(ies) or are intolerant to or refused standard therapy(ies).
• •Clinically measurable disease with at least 1 injectable lesion ≥ 3 mm in longest diameter; an injectable lesion is defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable intralesional injection.
• •No known bleeding diathesis or coagulopathy that would make intratumoral injection or biopsy unsafe
• •The entry laboratory criteria for subject eligibility must be less than or equal to Grade 1 adverse event levels for the parameters tested as defined by CTCAE v5.0:
• •* Bone Marrow Function:
• •* Hemoglobin (Hb) \> LLN 10 g/dL
• •* White Blood Cell Count (WBC) \> LLN 3,000 cells/mcL
• •* Platelet count (PLT) \> LLN - 75,000 /mcL
• •* Blood Coagulation Parameters
• •* PT, INR \< 1.5 x institutional ULN unless patient is therapeutically anticoagulated. If on anticoagulation PT/INR need to be within appropriate anticoagulation limits for the clinical indication. Patients who are receiving anticoagulants may participate in the trial if their anticoagulation can be stopped safely for several days at the time of biopsy.
• •* Renal Function
• •* Serum Creatinine (SCr) \< 1 - 1.5 x baseline; \< 1 1.5 x ULN
• •* Hepatic Function:
• •* Blood bilirubin \< 1 - 1.5 x ULN if baseline was normal; \< 1 1.5 x baseline if baseline was abnormal
• •* Serum Alanine Aminotransferase (ALT) \< 1 - 3 x ULN if baseline was normal; 1.5 3 x baseline if baseline was abnormal
• •* Serum Aspartate Aminotransferase (AST) \< 1 - 3 x ULN if baseline was normal; 1.5 3 x baseline if baseline was abnormal
• •* Alkaline Phosphatase (ALP) \< 1 - 2.5 x ULN if baseline was normal; 2 2.5 x baseline if baseline was abnormal
• •* Gamma Glutylamyltransferase (GGT) \< 1 - 2.5 x ULN, if baseline was normal; 2 2.5 x baseline if baseline was abnormal
• •Males and females of reproductive potential must agree to continuously use adequate contraception prior to study entry and for up to 6 months thereafter. A female is of childbearing potential unless she has had a surgical procedure that would accomplish sterility such a bilateral tubal ligation, hysterectomy or has not had menses for the past 12 months.
• •Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment
• •Patient or legal representative must understand and sign a written informed consent form.