Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 136

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 136
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 liver metastases are the most common indication for liver resection, but selected
patients with neuroendocrine, breast, lung and melanoma also benefit from resection of liver metastases. Other common indications for
liver resection include primary liver tumors such as hepatocellular carcinoma and intra-hepatic cholangiocarcinoma.

Montréal, Canada (recruiting)

We have initiated, in collaboration
with McGill University Health Center in Montréal, Canada, a clinical study to evaluate the feasibility and safety of intratumoral
Alpha DaRT for the treatment of liver metastases of colorectal cancer in approximately 10 patients. We plan to test the effect of the
Alpha DaRT technology on liver metastases during a two-staged hepatectomy. This unique clinical scenario is designed to allow us to implant
Alpha DaRT sources in right-sided liver metastases during the first operation and resect the right liver containing the sources during
the second operation. Thus, we believe a complete histopathological evaluation of liver metastases following Alpha DaRT administration
can be performed, after which we will be able to evaluate the effect of Alpha DaRT sources on liver metastases with different histopathological
growth patterns.

The rationale for evaluating
Alpha DaRT with this approach is multi-fold. First, we believe Alpha DaRT may elicit an immunological response, thus through treatment
of a single liver metastasis, we believe there could be reduction in metastases throughout the remaining liver. We believe a reduction
in metastases may also reduce the risk of future metastases from arising. Secondly, during the time between the two stages of the hepatectomy,
patients are normally not receiving metastasis-directed therapy, but in this study their remaining lesions will be receiving Alpha DaRT
during the period between surgical procedures. Third, we believe there may be synergy between Alpha DaRT and chemotherapy, which could
further improve outcomes.

The study’s primary
objectives are to evaluate the safety and feasibility of Alpha DaRT implanted in liver metastases. The secondary objectives are to evaluate
the pathological and radiological response of liver metastases to Alpha DaRT. Exploratory objectives include the immunological effects
of Alpha DaRT treatment and stratification of the differences in response to Alpha DaRT by histopathological growth patterns.

The first patient in this
trial was treated in May 2024. The clinicians observed a reduction of 18% in dimension of a treated lesion after one week, and at the