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

NCT05323253 | Recruiting DMC FDA Device

• 1 other identifier: CTP-SCC-03
• Study Type: interventional
• Target: 86
• Locations: 3 countries
• Sites: 30

Brief 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.

Conditions

Recurrent Squamous Cell Carcinoma

Keywords

Squamous Cell Carcinoma; Recurrent Squamous Cell Carcinoma; Alpha emitting radiation; Carcinoma, Squamous; Skin Cancer; Brachytherapy

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  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

  From Day 14 until 52 weeks

• Duration of Response

  Assess the Duration of Response (DOR) of DaRT as treatment for Recurrent SCC

  6 months from from first demonstration of CR or PR after Alpha DaRT seeds insertion.

Secondary Outcomes (7)

• Progression Free Survival

  Up to 12 months after DaRT seed insertion

• Overall Survival

  Up to 12 months following DaRT insertion

• Time of Local Control

  Up to 12 months following DaRT insertion

• Patients Quality of Life Assessment

  On 14 days,12 weeks and 52 weeks following DaRT insertion

• DaRT-related Adverse Events

  Up to 12 months following DaRT insertion

Study Arms (1)

DaRT seeds

EXPERIMENTAL

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.

Device: DaRT seeds

Interventions

DaRT seeds DEVICE

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.

Also known as: DaRT

DaRT seeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Interstitial implant indication validated by multidisciplinary team.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
• Life expectancy ≥12 months.
• Subjects male/ female ≥18.
• Willing and have the ability to provide signed Informed Consent.
• Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 3 months after the DaRT insertion visit.
• Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
• Blood tests values:

You may not qualify if:

• 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
• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
• Patients receiving any of the following within 4 weeks of enrollment:
• Antineoplastic systemic chemotherapy or biological therapy
• Immunotherapy
• Investigational agents other than the study intervention
• Radiation therapy
• Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
• Longest tumor diameter \>7 cm.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (30)

Banner Health MD Anderson Phoenix

Gilbert, Arizona, 85234, United States

RECRUITING

Dignity Health Cancer Institute

Phoenix, Arizona, 85004, United States

COMPLETED

Alliance Dermatology

Phoenix, Arizona, 85032, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Day Star Skin and Cancer Center

DeLand, Florida, 32720, United States

RECRUITING

Integrity Research Clinical Associates

Delray Beach, Florida, 33445, United States

RECRUITING

Palm beach Dermatology Group

Delray Beach, Florida, 33484, United States

RECRUITING

Hollywood Dermatology

Hollywood, Florida, 33021, United States

RECRUITING

University of Miami

Miami, Florida, 33101, United States

RECRUITING

Baptist Health South Florida MCI

Miami, Florida, 33176, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

COMPLETED

Beer Dermatology

West Palm Beach, Florida, 33401, United States

RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Schweiger Dermatology Group

Hackensack, New Jersey, 07601, United States

RECRUITING

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

RECRUITING

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

RECRUITING

Northwell Health

Queens, New York, 11375, United States

SUSPENDED

New York Medical Skin Solutions

Rockaway Park, New York, 11694, United States

RECRUITING

MDCS Dermatology

Smithtown, New York, 11787, United States

RECRUITING

West Cancer Center

Germantown, Tennessee, 38138, United States

WITHDRAWN

Gulf Coast Cancer Center

Houston, Texas, 77008, United States

RECRUITING

University Cancer & Diagnostic Center

Houston, Texas, 77089, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

WITHDRAWN

Dermatology of Seattle and Bellevue

Bellevue, Washington, 98004, United States

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, Canada

RECRUITING

Rambam Medical Center

Haifa, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, 9777605, Israel

RECRUITING

Belinson-Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Skin Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Liron Dimnik

CONTACT

+972-2-3737-210; LironD@alphatau.com

Aviya Hoida

CONTACT

+972-2-3737-210; aviyah@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an International Multicenter, Pivotal, Single Arm, Open Label pivotal trial with DaRT for the treatment of Recurrent Cutaneous Squamous Cell Carcinoma

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 12, 2022
• Study Start: September 21, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-05

Locations

CA (1); IL (4); US (25)