Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 138

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 138
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.0. Secondary endpoints include
preliminary efficacy, measured by assessing the ORR at one and three months after Alpha DaRT source insertion according to RECIST v. 1.1
criteria, and tumor coverage.

The first patient in this
trial was treated in October 2024. Ten Alpha DaRT sources were delivered into a lymph node metastasis in the mediastinum, leading to a
41.6% reduction in observed tumor volume after one month, and a 52.7% reduction in observed tumor volume after two months, as well as
a reduction in FDG uptake during a PET scan, with no treatment-related adverse events as of Jan 15, 2025.

SCC of the vulva - Cambridge University
Addenbrooke’s Hospital, UK (recruiting)

We are currently conducting,
in collaboration with the Addenbrooke’s Hospital of the Cambridge University Hospitals NHS Trust, a study to evaluate the safety
and efficacy of the Alpha DaRT technology for the treatment of primary and recurrent SCC of the vulva. We expect that ten patients will
be evaluated in this study, with the primary objective being the safety, feasibility and tolerability, and the secondary objective being
the effectiveness of the treatment. We also plan to measure the immunological response. We treated the first patient in this study in
May 2023.

Breast cancer - Hadassah
Medical Center, Israel (recruiting)

We have initiated a
trial at Hadassah Medical Center in Jerusalem, Israel, for the treatment of newly diagnosed or recurrent breast carcinoma in frail
or elderly patients. Recruitment is open for up to 10 women, age 65 of older, or younger if unfit for standard of care, with tumors
of the breast of up to 4 cm in the longest dimension, whose tumors are non-resectable with radical surgery or who do not wish to
undergo surgery. The primary endpoints of the study are feasibility, as measured by the successful placement of the Alpha DaRT
sources, and safety, by assessing the frequency, severity and causality of acute SAEs related to Alpha DaRT source insertion,
according to CTCAE version 5.0. Secondary endpoints include preliminary efficacy, measured by assessing the ORR at multiple points
in time after Alpha DaRT source insertion, according to RECIST v. 1.1 criteria.

TARGETS Trial - Hadassah
Medical Center, Israel (recruiting)

In lieu of