A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer

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.

Trial Details

NCT ID
NCT07693751
Phase
PHASE1 / PHASE2
Sponsor
SOTIO Biotech a.s.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • SOT109
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327
  • Faifax, Virginia, United States
  • Chisinau, Moldova|47.00902,28.85938

Key Eligibility Criteria

  • ≥18 years of age on the day of signing the ICF
  • Able to understand, sign, and provide written informed consent to participate in the trial
  • Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1. Patients with ECOG performance score 2 will be discussed with …
  • Estimated life expectancy ≥3 months as assessed by the investigator

For full eligibility, visit ClinicalTrials.gov.

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