JERUSALEM, July 15, 2026
Alpha Tau Medical announced the successful treatment of the first patient in its ADMIRE clinical study evaluating Alpha DaRT® for immunocompromised patients with recurrent cutaneous squamous cell carcinoma (cSCC). The procedure was performed at Banner MD Anderson Cancer Center in Arizona, marking an important milestone in expanding Alpha DaRT to a patient population with limited treatment options and a significantly higher risk of recurrent skin cancer.
ADMIRE Study Targets High-Risk Immunocompromised Patients
The multicenter, open-label ADMIRE study is designed to evaluate intratumoral Alpha DaRT in patients with recurrent cSCC who are immunocompromised due to conditions such as organ transplantation, hematologic malignancies, or long-term immunosuppressive therapy for autoimmune diseases. The trial plans to enroll up to 28 patients across eight U.S. clinical sites, with the primary endpoint measuring objective response rate (ORR) according to RECIST v1.1, while secondary endpoints include progression-free survival, overall survival, and local tumor control over 12 months.
Localized Alpha Radiation Therapy Addresses Unmet Clinical Need
Immunocompromised individuals face a substantially greater risk of developing recurrent cSCC, with organ transplant recipients experiencing incidence rates up to 65 to 100 times higher than the general population. Many standard therapies present significant challenges for these patients, as immune checkpoint inhibitors may trigger transplant rejection, while repeated surgery and conventional radiation become increasingly difficult due to cumulative tissue damage and radiation exposure limits. Alpha DaRT is designed as a localized, single-procedure treatment that can potentially be repeated if tumors recur, providing an alternative therapeutic approach for patients with limited options.
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Program Expands Following ReSTART Trial Progress
The ADMIRE study builds upon Alpha Tau’s ReSTART pivotal trial, which recently completed enrollment for patients with recurrent cSCC. Investigators involved in ReSTART expressed interest in evaluating Alpha DaRT in immunocompromised patients who were previously excluded from participation. Through ADMIRE, Alpha Tau aims to generate clinical evidence supporting the use of Alpha DaRT in this underserved population while expanding development of its alpha-radiation technology for solid tumors with high unmet medical need.
Source: Alpha Tau Medical press release
