Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors

Inclusion Criteria:

• Subjects with histopathological confirmation of newly diagnosed (Cohort A) orlocally recurrent (Cohort B) malignant cutaneous lesions of the followinghistopathologies:

• SCC

• BCC

• Lentigo maligna melanoma (Dubreuilh melanoma)

• Carcinosarcoma

• Acceptable tumor locations include the following:

• Skin (facial, scalp, extremities, torso)

• Lips

• Eyelids

• Subjects with a tumor size ≤ 7 centimeters in the longest diameter.

• Target lesion technically amenable for full tumor coverage with the Alpha DaRTseeds.

• Measurable disease according to RECIST v1.1.

• Subjects over 18 years old.

• Subjects' ECOG Performance Status Scale is < 2.

• Subjects' life expectancy is more than 6 months.

• Platelet count ≥100,000/mm3.

• International normalized ratio of prothrombin time ≤1.8.

• Women of childbearing potential (WOCBP) will have evidence of negative pregnancytest.

• Subjects are willing to sign an informed consent form

Exclusion Criteria:

• Subject has a tumor with histology of one of the following:

• Keratoacanthoma

• Merkel cell carcinoma

• Sarcoma other than carcinosarcoma

• Metastatic disease (according to the TNM staging system - M1 patients are excluded)

• Patients with significant comorbidities that the treating physician deems mayconflict with the endpoints of the study (e.g., poorly controlled autoimmunediseases, vasculitis, etc.).

• Patients undergoing systemic immunosuppressive therapy excepting intermittent, briefuse of systemic corticosteroids.

• Volunteers participating in another interventional study in the past 30 days whichmight conflict with the endpoints of this study or the evaluation of response ortoxicity of DaRT.

• High probability of protocol non-compliance (in opinion of investigator).

• Subjects not willing to sign an informed consent.

• Women who are pregnant or breastfeeding.