Silexion Therapeutics Corp. reported on September 30, 2026, that the first patient has been successfully dosed in a global Phase 2/3 clinical trial evaluating its lead candidate, SIL204, for locally advanced pancreatic cancer. The treatment was administered at Tel Aviv Sourasky Medical Center (TASMC) in Israel, marking the initiation of active clinical execution for the program.
The trial is a prospective, randomized, controlled, multinational, open-label study designed to evaluate the efficacy and safety of SIL204 in combination with standard chemotherapy compared to chemotherapy alone. The study is structured with an initial safety run-in cohort of approximately 18 patients, followed by a global expansion to enroll a randomized cohort of approximately 166 patients.
Silexion states that the trial enrolls newly diagnosed, treatment-naïve adult patients with unresectable Stage 3 locally advanced pancreatic cancer who have tumors harboring a confirmed KRAS mutation. The treatment regimen combines direct intratumoral administration via an endoscopic ultrasound (EUS)-guided procedure with subcutaneous abdominal injections. This dual-route strategy aims to address the dense tumor stroma and provide systemic exposure.
Tel Aviv Sourasky Medical Center serves as the anchor clinical center in Israel. The company notes that additional Israeli oncology centers and leading academic medical institutions in Germany, approved under the European Union Clinical Trials Regulation framework by the Federal Institute for Drugs and Medical Devices (BfArM), are progressing through site activation and are expected to join the program in the coming months.
