A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

• Patients with recurrent cutaneous SCC histologically confirmed who have failed at least first line standard of care therapy who are not indicated for surgery and standard radiation therapy, or non alpha radiation brachytherapy technologies, and for whom no curative systemic treatment is available
• Histopathological confirmation following previous treatment
• Measurable disease
• One single lesion
• Tumor size </= 7cm
• Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye)
• ECOG PS 0-2
• No distant or nodal metastatic disease
• No T4 disease or perineural spread
• No previously untreated disease indicated for surgery or radiation
• No mucosal, vulvar, anal, or penile SCC
• No systemic immunosuppresive therapy
• No keratoacanthoma histology
• No clinically significant cardiovascular disease

• Primary
  • ORR
  • DoR
• Secondary
  • PFS
  • OS
  • Time of local control
  • QoL
  • Safety