This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
This trial phase represents an early or specialized stage of clinical development.
Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.
Alpha Tau Medical Ltd. (DRTS) is the sponsoring company for this trial. BiotechSign currently grades this company F (26/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.