Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma

Running, not enrolling · Not applicable

Conditions studied: Recurrent Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT05323253

Run by

Alpha Tau Medical LTD.

People needed

86

Starts

2022-09-21

Expected to finish

2027-04-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Leucocytes ≥3000mm3,
• Absolute neutrophil count ≥1500mm3,
• Platelets ≥100,000 mm3,
• Total bilirubin ≤ 1.5xULN (upper limit of normal)
• Aspartate Aminotransferase (AST) ≤2.5xULN,
• Serum Glutamic-Oxaloacetic Transaminase (SGOT) ≤2.5xULN,
• Serum Glutamic-Pyruvic Transaminase (SGPT) ≤2.5xULN,
• Alkaline Phosphatase ≤2.5xULN.
• Creatinine ≤ 2.0xULN or Creatinine Clearance ≥60 ml/min.
• INR (International Normalized Ratio) or Prothrombin time ≤1.5xULN.

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.
• Tumor with keratoacanthoma histology.
• Known hypersensitivity to any component of treatment.
• Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.
• Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.
• Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
• High probability of protocol non-compliance (in opinion of investigator).
• Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 3 months after the DaRT insertion visit.
• Breastfeeding or pregnant women

Where it is running

• Banner Health MD Anderson Phoenix — Gilbert, Arizona, United States
• Dignity Health Cancer Institute — Phoenix, Arizona, United States
• Alliance Dermatology — Phoenix, Arizona, United States
• UCLA — Los Angeles, California, United States
• Day Star Skin and Cancer Center — DeLand, Florida, United States
• Integrity Research Clinical Associates — Delray Beach, Florida, United States
• Palm beach Dermatology Group — Delray Beach, Florida, United States
• Hollywood Dermatology — Hollywood, Florida, United States
• University of Miami — Miami, Florida, United States
• Baptist Health South Florida MCI — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Beer Dermatology — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Schweiger Dermatology Group — Hackensack, New Jersey, United States
• New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Bassett Healthcare Network — Cooperstown, New York, United States
• Northwell Health — Queens, New York, United States
• New York Medical Skin Solutions — Rockaway Park, New York, United States
• MDCS Dermatology — Smithtown, New York, United States
• Gulf Coast Cancer Center — Houston, Texas, United States
• University Cancer & Diagnostic Center — Houston, Texas, United States
• Dermatology of Seattle and Bellevue — Bellevue, Washington, United States
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Rambam Medical Center — Haifa, Israel

Full record on ClinicalTrials.gov

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