722TiP CLAUDIO-01: A multicentric phase I/II trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care (SoC) in patients with gastric, gastroesophageal junction(GEJ), and pancreatic adenocarcinoma

SOT102 is an antibody-drug conjugate targeting CLDN18.2, based on a highly specific monoclonal antibody conjugated to PNU-159682, an anthracycline derivative, using site-specific conjugation technology. Preclinical data support the development of SOT102 in the clinical setting. CLAUDIO-01 is a multicenter, multimodular phase I/II trial in gastric/GEJ and pancreatic cancer patients in both advanced and first line. The trial consists of the following modules: • Part A: First-in-human, CLDN18.2 agnostic, single-agent dose escalation trial of SOT102 in advanced or metastatic gastric/GEJ or pancreatic cancer patients • Part B gastric, GEJ cohort/pancreatic cohort: CLDN18.2 agnostic dose escalation trial of SOT102 in combination with SoC for first-line treatment of patients with advanced or metastatic gastric/GEJ cancer (SoC: mFOLFOX with nivolumab) or pancreatic cancer (SoC: nab-paclitaxel/gemcitabine), which will start once monotherapy SOT102 dose level 3 in Part A is deemed safe The following expansion cohorts are planned upon identification of the recommended phase 2 dose (RP2D): • Part C gastric, GEJ/pancreatic cohort: Single-agent SOT102 in CLDN18.2 positive gastric/GEJ cancer patients after two or more prior systemic therapies and in pancreatic cancer after one or more prior systemic therapies. • Part D gastric, GEJ/pancreatic cohort: SOT102 in combination with SoC for first-line treatment in CLDN18.2 positive gastric/GEJ and pancreatic cancer patients Dose escalation follows an accelerated modified Fibonacci scheme with cohort sizes of 3+3 and includes safety observation periods. Monotherapy dose escalation is ongoing at the third dose level without dose-limiting toxicity. Enrollment to dose level 4 of Part A and to dose level 1 in both cohorts of Part B are planned to begin in June 2023. Primary objectives and endpoints: -To determine the MTD and RP2D of SOT102 as monotherapy and in combination with first-line SoC treatment (Parts A and B) - To assess the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by ORR (Parts C and D). NCT05525286, 31 August 2022. SOTIO Biotech AG. SOTIO Biotech AG.