Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 133

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 133
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 be the incidence, rate and severity of treatment-emergent AEs, graded according to CTCAE v5.0. Secondary endpoints will include
overall survival, progression-free survival using RECIST version 1.1, pain response at 30 days and 2 months post treatment as compared
to baseline, based on average pain scale using the brief pain inventory short form, and, for the cohort of patients with locally advanced
disease, the percentage of patients with tumors that became surgically resectable after Alpha DaRT treatment. Exploratory endpoints will
include change in CA 19-9 biomarker levels, a user experience questionnaire, and pain response per the brief pain inventory short form.

We are currently targeting
treatment of the first patient in Q2 2025.

French Multi-Center Study (planning)

Following receipt of authorization
of a clinical investigation from the French Ministry of Health, we are currently working to initiate a multi-center clinical study in
France examining the use of Alpha DaRT alongside capecitabine in treating locally advanced pancreatic cancer patients who have responded
or had stable disease with first-line modified FOLFIRINOX chemotherapy. Up to 40 patients who have been previously treated with 8 - 
12 cycles of modified FOLFIRINOX are expected to undergo Alpha DaRT insertion, and then three days later they will receive Capecitabine
for 2 months. Every 2 months after Alpha DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable,
if they should continue with therapy, or if they should pause therapy.

The primary objective of the
study will be to evaluate the safety of Alpha DaRT in combination with chemotherapy for the treatment of locally advanced pancreatic cancer
in subjects who have non-progressive disease following treatment with modified FOLFIRINOX, and the primary safety endpoint is expected
to be the overall incidence of treatment-related SAEs, with severity graded according to CTCAE version 5.0 criteria. Secondary endpoints
include tumor ORR, OS, PFS, and percentage of patients with certain resected tumors or tumors that become surgically resectable after
Alpha DaRT treatment. Exploratory endpoints include changes in PET scan metrics, CA19-9 biomarker levels and quality of life. We are currentlys
targeting treatment of the first patient in the second half of 2025.

French Single-Center Study (planning)

Following receipt of authorization