Actively Recruiting
A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Led by Alpha Tau Medical LTD. · Updated on 2025-12-02
86
Participants Needed
30
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with recurrent cutaneous squamous cell carcinoma confirmed by biopsy who have failed at least one standard treatment and are not candidates for surgery or standard radiation
- Histopathological confirmation within 6 months before enrollment without tumor treatment between biopsy and enrollment
- Measurable disease by RECIST version 1.1
- Ability to undergo a CT scan
- Tumor size 7 cm or less in longest diameter
- Only one lesion per patient
- Tumor must be accessible for complete coverage by DaRT seeds without obstruction by bone, major vessels, or vital organs
- Implant indication confirmed by a multidisciplinary team
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of 12 months or more
- Male or female aged 18 years or older
- Ability and willingness to provide signed informed consent
- Patients with reproductive potential must use effective birth control before treatment and for 3 months after DaRT insertion
- Women of childbearing potential must have a negative pregnancy test before treatment
- Blood tests within specified limits for leucocytes, neutrophils, platelets, bilirubin, liver enzymes, alkaline phosphatase, creatinine or creatinine clearance, and coagulation parameters
You will not qualify if you...
- Presence of distant or lymph node metastatic disease (N+ or M1)
- T4 tumor stage or perineural disease spread
- Untreated cutaneous squamous cell carcinoma eligible for surgery or radiation
- Mucosal, vulvar, anal, or penile squamous cell carcinoma
- Inability to cover entire tumor volume with DaRT seeds
- Tumor location inaccessible for seed placement due to bone, major vessels, or vital organs
- Inability to undergo a CT scan
- Use of systemic immunosuppressive therapy except brief corticosteroids
- Receipt of chemotherapy, immunotherapy, investigational agents, radiation therapy within 4 weeks before enrollment
- Live vaccines within 30 days before treatment
- Tumor larger than 7 cm in longest diameter
- Tumor with keratoacanthoma histology
- Known allergy to treatment components
- Significant cardiovascular disease or recent heart attack
- Medical or psychiatric conditions that compromise treatment tolerance or compliance
- Serious comorbidities affecting safety or treatment interpretation
- High risk of not complying with study protocol
- Participation in another interventional study within 30 days
- Active additional malignancy requiring treatment (except certain skin or cervical cancers)
- Refusal to use contraception before and after treatment
- Pregnancy or breastfeeding
- Tattoos or marks that cannot be hidden in study photos
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Banner Health MD Anderson Phoenix
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Dignity Health Cancer Institute
Phoenix, Arizona, United States, 85004
Completed
3
Alliance Dermatology
Phoenix, Arizona, United States, 85032
Actively Recruiting
4
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
5
Day Star Skin and Cancer Center
DeLand, Florida, United States, 32720
Actively Recruiting
6
Integrity Research Clinical Associates
Delray Beach, Florida, United States, 33445
Actively Recruiting
7
Palm beach Dermatology Group
Delray Beach, Florida, United States, 33484
Actively Recruiting
8
Hollywood Dermatology
Hollywood, Florida, United States, 33021
Actively Recruiting
9
University of Miami
Miami, Florida, United States, 33101
Actively Recruiting
10
Baptist Health South Florida MCI
Miami, Florida, United States, 33176
Actively Recruiting
11
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Completed
12
Beer Dermatology
West Palm Beach, Florida, United States, 33401
Actively Recruiting
13
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
14
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Schweiger Dermatology Group
Hackensack, New Jersey, United States, 07601
Actively Recruiting
16
New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
17
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Actively Recruiting
18
Northwell Health
Queens, New York, United States, 11375
Suspended
19
New York Medical Skin Solutions
Rockaway Park, New York, United States, 11694
Actively Recruiting
20
MDCS Dermatology
Smithtown, New York, United States, 11787
Actively Recruiting
21
West Cancer Center
Germantown, Tennessee, United States, 38138
Withdrawn
22
Gulf Coast Cancer Center
Houston, Texas, United States, 77008
Actively Recruiting
23
University Cancer & Diagnostic Center
Houston, Texas, United States, 77089
Actively Recruiting
24
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Withdrawn
25
Dermatology of Seattle and Bellevue
Bellevue, Washington, United States, 98004
Actively Recruiting
26
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Actively Recruiting
27
Rambam Medical Center
Haifa, Israel
Actively Recruiting
28
Hadassah Medical Center
Jerusalem, Israel, 9777605
Actively Recruiting
29
Belinson-Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
30
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
Research Team
L
Liron Dimnik
CONTACT
A
Aviya Hoida
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here