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

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Start date changed from estimate of Aug 29, 2026 to Aug 12, 2026
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: details revised at 1 of 11 entries
    • Site details revised at 3 of 3 sites
    • Study description expanded, about 2 words
  2. Study title shortened, about 24 wordsv4
  3. Start date: Jun 29, 2026 to Aug 29, 2026v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT07693751
Lead Sponsor SOTIO Biotech a.s.
Conditions
(from sponsor)		 Colorectal Cancer (Locally Advanced or Metastatic)
Related terms Colorectal Neoplasms, Neoplasm Metastasis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov