Silexion doses first patient in Phase 2/3 trial of SIL204 for pancreatic cancer

Silexion Therapeutics Corp. announced on September 30, 2026 that the first patient worldwide has been dosed in its Phase 2/3 clinical trial evaluating the company's lead candidate, SIL204, in patients with locally advanced pancreatic cancer.¹ The treatment was given at Tel Aviv Sourasky Medical Center, known as Ichilov, in Israel.¹

The study design is a prospective, randomized, controlled, multinational, Phase 2/3, open-label trial comparing SIL204 combined with standard-of-care chemotherapy against chemotherapy alone in patients with locally advanced pancreatic cancer.¹ Enrollment starts with a safety run-in cohort of about 18 patients, followed by expansion to a randomized cohort of roughly 166 patients globally.¹ Eligible patients must be newly diagnosed, treatment-naive adults with unresectable Stage 3 disease without distant metastases, and their tumors must carry a confirmed KRAS mutation.¹ SIL204 is given as a first-line regimen alongside chemotherapy chosen by the treating physician.¹

The drug is delivered through a dual-route approach combining direct intratumoral dosing via endoscopic ultrasound guidance to reach the primary pancreatic lesion, along with subcutaneous abdominal injections intended to address systemic exposure and possible micro-metastases.¹

Ilan Hadar, Chairman and CEO, called the dosing milestone a step toward active patient treatment and said the company aims for near-term preliminary readouts, according to the release.

Tel Aviv Sourasky Medical Center is currently the trial's anchor site in Israel, having received institutional ethics approval and authorization from the Israeli Ministry of Health.¹ Additional oncology centers in Israel and academic institutions in Germany, cleared under the EU Clinical Trials Regulation framework by Germany's BfArM, are moving through site activation and are expected to join in coming months.¹