A Study Testing SOT109 for the First Time in Patients, to Assess How Safe SOT109 is, How Well it Works, and How the Body Handles it in Patients With Advanced Colorectal Cancer That Can Not be Removed by Surgery or is Metastatic

SOT109 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called CDH17, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT109, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.

NCT Number	NCT07693751
Lead Sponsor	SOTIO Biotech a.s.
Conditions	Colorectal Cancer (Locally Advanced or Metastatic)
Enrollment	100 participants
Start Date	2026-08-29
Primary Completion	2027-11-29 (estimated)
Study Completion	2028-07-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-14