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Treatment of recurrent skin cancer using Alpha DaRT224

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

Not applicable Interventional Alpha Tau Medical LTD. · NCT05323253

This study is testing a new treatment called Alpha DaRT224 for people with recurrent skin cancer to see if it can help shrink tumors and improve their quality of life.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment86 (estimated)
Ages18 Years and up
SexAll
SponsorAlpha Tau Medical LTD. Industry-sponsored
Drugs / interventionschemotherapy, Immunotherapy, radiation
Locations30 sites (Gilbert, Arizona and 29 other locations)
Trial IDNCT05323253 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of Alpha DaRT224, a novel treatment involving the intratumoral administration of diffusing alpha-emitting radiation therapy, for patients with recurrent cutaneous squamous cell carcinoma. The study aims to enroll up to 86 participants and will assess the objective response rate, duration of response, safety, progression-free survival, overall survival, local control, and quality of life. DaRT seeds will be inserted into the tumors and removed after 14-21 days, with follow-up assessments conducted for up to six months.

Who should consider this trial

Good fit: Ideal candidates include patients with recurrent cutaneous squamous cell carcinoma who have failed at least first-line standard therapies and are not suitable for surgery or standard radiation.

Not a fit: Patients with non-recurrent squamous cell carcinoma or those who are candidates for curative surgery or standard radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent skin cancer who have limited treatment alternatives.

How similar studies have performed: While this approach is innovative, similar studies using alpha-emitting therapies have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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
2. Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment
3. Measurable disease according to RECIST v 1.1.
4. Ability to undergo a CT scan
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).
8. Interstitial implant indication validated by multidisciplinary team.
9. Eastern Cooperative Oncology Group (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 3 months after the DaRT insertion visit.
14. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
15. 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.

Exclusion Criteria:

1. Distant or nodal metastatic disease (according to the TNM \[tumor, nodes , and metastases\] staging system - N+ or M1 patients are excluded).
2. T4 disease or perineural spread of disease
3. Previously untreated cutaneous SCC indicated for surgery or radiation.
4. Mucosal, vulvar, anal and penile SCC.
5. Inability to fully cover the entire volume with DaRT seeds
6. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs
7. Inability to undergo a CT scan
8. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
9. Patients receiving any of the following within 4 weeks of enrollment:

   1. Antineoplastic systemic chemotherapy or biological therapy
   2. Immunotherapy
   3. Investigational agents other than the study intervention
   4. Radiation therapy
   5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
10. 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.
14. 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.
15. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
16. 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.
18. 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.
19. 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.
20. Breastfeeding or pregnant women
21. Tattoos or other identifying marks which can not be adequately hidden on digital photos

Where this trial is running

Gilbert, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Recurrent Squamous Cell CarcinomaSquamous Cell CarcinomaAlpha emitting radiationCarcinoma, SquamousSkin CancerBrachytherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.