Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 130

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 130
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Recruitment is open for up to 37 patients with locally advanced (Stage II or Stage III) or metastatic (Stage IV) pancreatic adenocarcinoma
which has been histologically and/or cytologically proven and which is not amenable to surgery, with a tumor lesion of less than four
cm in the longest dimension.

There are two short-term objectives
of this study: to evaluate the feasibility and safety of Alpha DaRT as assessed by the incidence of device-related AEs and SAEs, and to
evaluate the preliminary efficacy of Alpha DaRT for pancreatic cancer patients, as measured by ORR following the insertion of the sources,
and any observable change in CA19-9 as a marker of tissue damage. The long-term objectives include evaluating overall survival following
Alpha DaRT sources insertion, stent durability after Alpha DaRT source insertion, and change in quality of life as measured by patient
questionnaires.

The primary endpoints of the
study are: feasibility, as measured by the successful placement of the Alpha DaRT sources within the tumor or less than 5 mm from the
tumor, to be determined based on CT scan performed immediately following the insertion procedure; and safety, by assessing the frequency,
severity and causality of acute AEs and SAEs related to Alpha DaRT sources insertion. AEs and SAEs will be assessed and graded according
to CTCAE version 5.0. Other safety endpoints include all AEs and SAEs related and unrelated to the study treatment, vital signs, blood
and urine tests, and subject and personnel radiation levels.

Secondary endpoints
include: preliminary efficacy, measured by assessing the ORR four to six weeks after Alpha DaRT sources insertion as assessed by CT
scan, changes in CA19-9, which serves as a marker of tissue damage (elevation during treatment, and reduction as a result of tumor
ablation), and assessments of overall survival, local control, regional control, distal metastases following Alpha DaRT sources
insertion for 24 months, or until patients are lost to follow-up or disease progression, stent durability (assessed by the time
elapsed from Alpha DaRT insertion to the need for follow up referral for endoscopic retrograde cholangiopancreatograph, or ERCP, for
stent change due to tumor ingrowth), and change in patient-reported quality of life measures 35 and 60 days after Alpha DaRT source
insertion. For the first five patients,