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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

NCT07693751 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Cancer (Locally Advanced or Metastatic)

Interventions

BIOLOGICAL

SOT109

SOT109 is a CDH17-directed monoclonal antibody conjugated to a linker-payload, exatecan

Sponsors & Collaborators

  • SOTIO Biotech a.s.

    lead INDUSTRY

Principal Investigators

  • Josep Tabernero, M.D., Ph.D. · Vall d'Hebron University Hospital (HUVH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-29
Primary Completion
2027-11-29
Completion
2028-07-04
FDA Drug
Yes

Countries

  • United States
  • Moldova

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07693751 on ClinicalTrials.gov