SOT102

P1/2, N=160, Recruiting, SOTIO Biotech a.s. | Suspended --> Recruiting | N=269 --> 160 | Trial completion date: Jun 2025 --> Jun 2028 | Trial primary completion date: Dec 2023 --> Dec 2027

P1/2, N=269, Suspended, Sotio Biotech Inc. | Recruiting --> Suspended

Outlining the engineering of a Claudin18.2 targeting antibody; Outlining the preclinical development of SOT102, a novel PNU-based antibody– drug conjugate targeting Claudin18.2 -expressing cancers; Exploring combinations with immunotherapy

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. 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).