Clinical Pipeline
Advancing multiple global trials across a wide range of tumors
Global Clinical Program
Alpha Tau’s global clinical pipeline is advancing rapidly. Our U.S clinical studies are conducted under an Investigational Device Exemption (IDE) granted by the Food and Drug Administration (FDA). This designation means that, while the Alpha DaRT is still not currently authorized or available for commercial use in the U.S., the FDA has already reviewed the technology, safety data, and clinical plans, and has authorized us to evaluate the Alpha DaRT in patients in the United States in the context of clinical trials. We are currently conducting clinical studies of multiple cancer types and have achieved an exciting milestone of five simultaneously active IDEs.
England
Clinical Trials Coming Soon
Japan
Clinical Trials Coming Soon
5 Investigational Device Exemptions IDEs
Ongoing Clinical Trials
ADMIRE – Alpha Dart Management for Immunocompromised patients with REcurrent cSCC
Alpha Radiation Emitters Device for the Treatment of Malignant Cutaneous Tumors
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Alpha radiation emitters device in combination with check point inhibitor for the treatment of recurrent unresectable or mHNSCC
ReSTART – Recurrent SCC (Squamous Cell Carcinoma) Treatment with Alpha DaRT Radiotherapeutics
Frequently Asked Questions about Clinical Pipeline
What is an Investigational Device Exemption (IDE), and what does it mean that Alpha Tau has five active IDEs?
An Investigational Device Exemption (IDE) is an authorization granted by the U.S. Food and Drug Administration (FDA) that allows the use of a medical device even if it has not been approved for commercial use, to be used under specific circumstances in approved clinical studies involving human subjects. Receiving an IDE means that the FDA has reviewed the device technology, preclinical and available safety data, and proposed clinical study design, and has determined that the study may proceed in the United States. Alpha Tau currently holds five simultaneously active IDEs, each corresponding to a separate cancer indication. This milestone reflects the breadth of Alpha Tau’s clinical development program and means that the FDA has authorized the evaluation of Alpha DaRT across multiple tumor types in parallel – an important indicator of the technology’s potential versatility and the Company’s advancing clinical trajectory.
What range of cancer types and clinical settings are being studied in Alpha Tau’s trial program?
Alpha Tau’s clinical pipeline spans a broad range of solid tumor types, including skin, head and neck, pancreatic, brain, lung, prostate, and liver cancers. These studies cover both superficial tumors, such as skin and certain head and neck lesions and deep-seated tumors located in internal organs. The clinical program is also evaluating Alpha DaRT in diverse clinical settings: as a stand-alone local therapy, in combination with systemic agents such as chemotherapy or checkpoint inhibitors, and in patients with varying stages of disease, including both locally advanced and metastatic cancers as well as recurrent disease. This range of indications and treatment strategies reflects the tumor-agnostic potential of the Alpha DaRT platform and is intended to generate data across a wide spectrum of patient needs.
In which countries are Alpha DaRT clinical trials currently active, and is the program expanding?
Alpha DaRT clinical trials are currently active in the United States, Canada, Israel, Italy, and France. Trial sites within these countries include leading academic medical centers and cancer research institutions. Alpha Tau has also indicated plans to commence new trials anticipated in Japan and England. This global, multi-center approach is designed to support the collection of clinical evidence across diverse patient populations and healthcare settings, and to advance the regulatory pathway in multiple geographies simultaneously.
Are any of Alpha Tau’s clinical trials studying Alpha DaRT in combination with other therapies?
Yes. Several of Alpha Tau’s clinical trials are specifically designed to evaluate Alpha DaRT in combination with systemic therapies, including chemotherapy and immune checkpoint inhibitors. For example, the clinical program includes a study of Alpha DaRT combined with chemotherapy in patients with locally advanced and metastatic pancreatic cancer, as well as a study evaluating Alpha DaRT in combination with a checkpoint inhibitor for recurrent, unresectable, or metastatic head and neck squamous cell carcinoma (HNSCC). The rationale for these combination strategies is based on the hypothesis that the localized tumor destruction caused by Alpha DaRT may complement the effects of systemic treatment and may also help stimulate an immune response that could extend beyond the treated site. These combination trials represent an important pillar of Alpha Tau’s clinical strategy.
How can someone find detailed information about a specific Alpha DaRT clinical trial, including eligibility and participating sites?
Each clinical trial listed on the Alpha Tau Clinical Pipeline page includes a direct link to its corresponding entry on www.clinicaltrials.gov, the U.S. government’s database of publicly and privately supported clinical studies. On clinicaltrials.gov, visitors can find comprehensive information about each study, including its purpose, eligibility criteria, participating sites and locations, study design, contact details, and current enrollment status. The Alpha Tau Clinical Pipeline page also provides filters by country and therapeutic area to help visitors quickly identify trials relevant to their area of interest. For additional guidance, visitors may contact Alpha Tau directly through the contact form on the website.