DaRT Seeds for Skin Cancer

(DaRT Trial)

Not yet recruiting at 10 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DaRT, which stands for Diffusing Alpha-Emitters Radiation Therapy, designed for skin cancer patients with compromised immune systems. The goal is to evaluate DaRT's effectiveness in shrinking tumors and preventing cancer spread. Researchers also examine how long patients live without their cancer worsening. Individuals with a confirmed diagnosis of cutaneous squamous cell carcinoma (a type of skin cancer) who are willing to undergo multiple CT scans might be suitable candidates for this trial. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research and potentially benefit from a novel treatment approach.

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.

What prior data suggests that DaRT is safe for treating skin cancer?

A previous study with 10 patients found that DaRT (Diffusing Alpha-Emitters Radiation Therapy) was well tolerated, causing few unwanted reactions. Another review confirmed this, showing DaRT successfully treated squamous cell carcinoma, a type of skin cancer, and was generally safe for patients. These findings suggest that DaRT is safe for human use, with few reports of serious issues. This is promising for those considering joining a trial with DaRT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for skin cancer, such as surgery, radiation therapy, and chemotherapy, DaRT (Diffusing Alpha emitters Radiation Therapy) introduces a new way of targeting cancer cells. Researchers are excited about DaRT because it uses tiny radioactive seeds to deliver alpha radiation directly into the tumor, which can potentially minimize damage to surrounding healthy tissues. This targeted method could be particularly beneficial for immunocompromised patients, offering a more precise approach to treating malignant cutaneous squamous cell carcinoma. By focusing the radiation in this way, DaRT might reduce side effects and improve outcomes compared to traditional radiation methods.

What evidence suggests that DaRT is effective for skin cancer?

Research has shown that DaRT (Diffusing Alpha-Emitters Radiation Therapy), which participants in this trial will receive, holds promise for treating skin cancer. Studies have found that many patients with squamous cell carcinoma experienced complete tumor disappearance. This treatment has been tested on over 6,000 solid tumors, demonstrating both safety and effectiveness. Data from various studies also indicate that DaRT is a safe option for managing difficult-to-treat or recurrent skin cancers. Overall, these findings support DaRT as a potentially effective treatment for skin cancer. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11240433/

Extended Follow-Up Outcomes from Pooled Prospective ... We analyzed data pooled from several ongoing prospective studies that are evaluating the use of Alpha DaRT for squamous cell carcinoma or basal ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804784

Diffusing Alpha-Emitter Radiation Therapy for Recurrent or ... This cohort study suggests the feasibility and preliminary safety of DaRT in the management of recurrent or unresectable skin cancers.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05323253

NCT05323253 | A Clinical Study to Assess the Efficacy and ... This study is a prospective multicenter, pivotal, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224

4. jrpr.org jrpr.org/journal/view.php?number=1171

A Comprehensive Review of Diffusing Alpha-Emitters ... Clinical trials have shown high complete response rate in squamous cell carcinoma, with minimal side effects, suggesting DaRT's feasibility and ...

5. alphatau.com alphatau.com/publications

Alpha DaRT | Publications Alpha DaRT has proven safety and efficacy on all solid tumors tested (over 6000) and was published in over 16 articles in the most esteemed scientific ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10176125/

Feasibility and Safety of Diffusing Alpha-Emitter Radiation ... This cohort study enrolled 10 patients with skin cancers who successfully underwent DaRT. Treatment was well tolerated with adverse events ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20558570

A Clinical Study to Assess the Efficacy and Safety of Alpha ... A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma. Print ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0360301622031881

Diffusing Alpha-Emitters Radiation Therapy Promotes a ... DaRT promotes a “hot” tumor microenvironment and changes in immune suppression that lead to a potentiation of aPD-1 blockade induced effector T cell function.