Clinical Study Protocol for Cutaneous SCC for Immunocompromised Patients

NCT06615635 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CPT-SCC-04
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 11

Brief Summary

This is a multi-center clinical study enrolling up to 28 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. Secondary objectives are to:

1. 1.Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.
2. 2.Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
3. 3.Assess Local control up to 12 months after DaRT insertion.

Conditions

Squamous Cell Carcinoma; Alpha Radiation; Immunocompromised; Carcinoma, Squamous; Skin Cancer; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• objective response rate

  • Assessment of the objective response rate (ORR) determined by the best overall response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).

  From Day 14 until 52 weeks

Secondary Outcomes (3)

• Progression Free Survival

  Up to 12 months after DaRT seed insertion

• Overall Survival

  Up to 12 months after DaRT seed insertion

• Local control

  Up to 12 months after DaRT seed insertion

Other Outcomes (1)

• Safety Objectives

  Up to 12 months following DaRT insertion

Study Arms (1)

DaRT seeds

EXPERIMENTAL

Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients

Device: DaRT seeds

Interventions

DaRT seeds DEVICE

Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients

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 cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.
• \. Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. 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) as decided by treating physician and sponsor.
• \. Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male/ female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. 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 1 year 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:
• Platelets ≥100,000 mm3,
• Total bilirubin ≤ 1.5xULN,
• AST ≤2.5xULN,
• SGOT ≤2.5xULN,
• SGPT ≤2.5xULN,
• Alkaline Phosphatase ≤2.5xULN.
• Creatinine Clearance ≥30 ml/min.
• INR or Prothrombin time ≤1.5xULN.

You may not qualify if:

• \. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).
• \. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. 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. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. 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). 17. 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 1 year after the DaRT insertion visit.
• \. Breastfeeding or pregnant women 21. Tattoos scars, body jewelry (e.g., nose rings) or other identifying marks which cannot be adequately hidden on digital photos or other identifying marks which cannot be adequately hidden on digital photos

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (11)

Banner Health

Gilbert, Arizona, 35234, United States

Location

Us Dermatology Parthners

Phoenix, Arizona, 85006, United States

Location

Alliance Dermatology

Phoenix, Arizona, 85032, United States

Location

Integrity Research Clinical Associates

Boca Raton, Florida, 33445, United States

Location

Hollywood Dermatology

Hollywood, Florida, 33201, United States

Location

Palm Beach Dermatology Group

Palm Beach, Florida, 33848, United States

Location

Day Star Skin Cancer Center

Poinciana, Florida, 33445, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Bassett Healthcare

Cooperstown, New York, 13326, United States

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

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 Immunocompromised Cutaneous Squamous Cell Carcinoma

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 26, 2024
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-09

Locations

IL (1); US (10)