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MelanomaOpen to EnrollmentPhase 2

SKIN SQUAMOUS CELL: Recurrent: Intratumoral XRT: Alpha DaRT224-03

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

Study snapshot

Title
Alpha Tau CTP-SCC-03 (squamous cell skin- DaRT224)
Malignancy
Squamous cell skin cancer
Stage
Stage 4
Disease setting
Recurrent
Line of therapy
2nd line
Investigational agent
DaRT224
Drug class
Intratumoral encapsulated radium-224
Principal investigator
Noam VanderWalde, MD
Sponsor
Alpha Tau Medical
Path
Squamous cell carcinoma
Randomized
No
ClinicalTrials.gov ID
NCT05323253

Eligibility and objectives

Key eligibility criteria details

  • 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

Objective

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

Treatment details