Intratumoral Administration of Daromun in Non-melanoma Skin Cancer Patients

Exclusion Criteria

• •Previous or concurrent cancer type that is distinct from the cancers being evaluated in this study, except any cancer curatively treated more than 2 years prior to study entry.
• •Patients may have previously received topical or systemic chemotherapy, immunotherapy or radiation therapy on the tumor sites. Such therapies must be completed at least 4 weeks prior to study drug administration.
• •Patients with node positive BCC/cSCC who are candidate to SHH inhibitor or checkpoint inhibitor therapy.
• •Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. In particular a documented test for HIV, HBV and HCV excluding active infection is needed.
• •History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
• •Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
• •Known arterial aneurysms.
• •INR \> 3.
• •Uncontrolled hypertension.
• •Known uncontrolled coagulopathy or bleeding disorder.
• •Known hepatic cirrhosis or severe pre-existing hepatic impairment.
• •Moderate to severe respiratory failure.
• •Active autoimmune disease.
• •Patient requires or is taking systemic corticosteroids (\>5 mg/day) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
• •Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.
• •Pregnancy or breast-feeding.
• •Ischemic peripheral vascular disease (Grade IIb-IV).
• •Severe diabetic retinopathy.
• •Recovery from major trauma including surgery within 4 weeks prior to enrollment.
• •Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.
• •Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.