Skin Cancer Clinical Study (18 yrs+)

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 Description

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.

Brief Summary

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.

Condition or Disease

Cutaneous Squamous Cell Carcinoma

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	86
Primary Outcome Measures	1. Objective Response Rate (ORR) of DaRT as treatment for Recurrent SCC established by the confirmed Best Overall Response (BOR), with confirmation at least 4 weeks after initial assessment. 2. Assess the Duration of Response (DOR) of DaRT as treatment for Recurrent SCC
Actual Study Start Date:	September 2022
Estimated Primary Completion Date:	December 2025

Eligibility Criteria

Ages Eligible for Study:	18 & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Cutaneous Squamous Cell Carcinoma

Inclusion Criteria

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
Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment
Measurable disease according to RECIST v 1.1
Ability to undergo a CT scan
Tumor size ≤7 cm, at the longest diameter
Single lesion per subject
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).

Exclusion Criteria

Distant or nodal metastatic disease (according to the TNM [tumor, nodes , and metastases] staging system – N+ or M1 patients are excluded)
T4 disease or perineural spread of disease
Previously untreated cutaneous SCC indicated for surgery or radiation
Mucosal, vulvar, anal and penile SCC
Inability to fully cover the entire volume with DaRT seeds
Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs
Inability to undergo a CT scan

ADDITIONAL DETAILS

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Cutaneous Squamous Cell Carcinoma Study (18 Years+)