This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.
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.