This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:
1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion. 2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months. 3. Assess Local control up to 12 months after DaRT insertion.
1. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.
Platelets ≥100,000 mm3,
Total bilirubin ≤ 1.5xULN,
AST ≤2.5xULN,
1. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).
Antineoplastic systemic chemotherapy or biological therapy
Immunotherapy
Investigational agents other than the study intervention
Alpha Tau Medical LTD.
Lead sponsor