DaRT Seeds for Skin Cancer

(DaRT Trial)

Overseen By Aviya Hoida

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alpha Tau Medical LTD.

Must not be taking: Antineoplastic, Immunotherapy, Radiation, others

Disqualifiers: Metastatic disease, T4 disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

28 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain treatments, such as chemotherapy, immunotherapy, or radiation therapy, at least 4 weeks before joining. If you're on these treatments, you would need to stop them before participating.

How is the DaRT treatment for skin cancer different from other treatments?

DaRT (Diffusing Alpha-emitters Radiation Therapy) is unique because it involves placing radioactive seeds directly into the tumor, which emit alpha particles to destroy cancer cells locally. This method is different from traditional treatments like surgery or external radiation, as it targets the tumor from within, potentially reducing damage to surrounding healthy tissue. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for immunocompromised patients with a type of skin cancer called cutaneous squamous cell carcinoma (SCC). Participants should not have had prior radiation therapy in the area to be treated and must be able to attend follow-up visits. Those who are pregnant, breastfeeding, or have other cancers are excluded.

Inclusion Criteria

Measurable disease according to RECIST v 1.1

Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure

Patients with reproductive potential must practice acceptable effective methods of birth control

Exclusion Criteria

Serious medical comorbidities that may affect subject compliance and/or interpretation of treatment safety or effectiveness

Breastfeeding or pregnant women

Tattoos, scars, body jewelry, or other identifying marks which cannot be adequately hidden on digital photos

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intratumoral placement of Alpha DaRT-224 sources into tumors, followed by removal after 14-21 days

3 weeks

1 visit for insertion, 1 visit for removal

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ORR, PFS, OS, and local control

52 weeks

Treatment Details

Interventions

• DaRT

Trial Overview The study is testing DaRT seeds, a form of radiation treatment for skin cancer. It aims to see how well these seeds can control the growth of SCC when placed directly into tumors. Up to 28 people will join this study at multiple centers.

Participant Groups

Group I: DaRT seeds Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Alpha Tau Medical LTD.

Lead Sponsor

Trials

28

Recruited

920+

References

1. Greece pubmed.ncbi.nlm.nih.gov

Differential expression of p-mTOR in cutaneous basal and squamous cell carcinomas likely explains their different response to mTOR inhibitors in organ-transplant recipients. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

The molecular genetics of eyelid tumors: recent advances and future directions. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Vascular tumors have increased p70 S6-kinase activation and are inhibited by topical rapamycin. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Reviewing the genetic alterations in high-risk cutaneous squamous cell carcinoma: A search for prognostic markers and therapeutic targets. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Topically applied imiquimod inhibits vascular tumor growth in vivo. [2018]