NCT06615635

Clinical Study Protocol for Cutaneous SCC for Immunocompromised Patients

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a pivotal multicenter, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of of Immunocompromised Patients with Cutaneous Squamous Cell Carcinoma The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. Alpha DaRT sources will be inserted into Cutaneous Squamous Cell Carcinoma tumors and will be removed following 14-21 days. The The objective response rate (ORR), which is calculated as the percent of patients achieving an objective response. Best overall response using the Response Evaluation Criteria in Solid Tumors guidelines (RECIST v1.1). Best overall response is assessed starting from DaRT removal. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.

Conditions

• Squamous Cell Carcinoma
• Alpha Radiation
• Immunocompromised
• Carcinoma, Squamous
• Skin Cancer
• Brachytherapy

Interventions

Type	Name	Description
DEVICE	DaRT seeds	Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients

Timeline

• Start date: 2025-12-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-09-26
• Last updated: 2025-12-02

Locations

11 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study