A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

Active:	Yes
Cancer Type:	Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT05323253
Trial Phases:		Protocol IDs:	CTP-SCC-03 (primary) NCI-2022-10859
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Alpha Tau Medical LTD.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05323253

Summary

This is a multi-center clinical study enrolling up to 86 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, as well as to assess the Duration of Response (DOR) 6 months from initial
response. Secondary objectives are to assess the safety of DaRT, and to assess the
progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR),
local control and quality of life (QOL) for patients treated with DaRT.

Objectives

This study is a prospective multicenter, pivotal, single arm, open label clinical study to
assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of patients
with recurrent cutaneous squamous cell carcinoma.

The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial
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. DaRT seeds will be inserted into recurrent Squamous Cell
Carcinoma (SCC) tumors and will be removed following 14-21 days.

The Objective Response Rate (ORR) will be determined based on the confirmed Best Overall
Response (BOR) following DaRT insertion. Duration of Response (DOR) will be assessed for up
to 6 months from initial response is documented. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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