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

Source: https://onco.cc/trials/nct07693751/  
OnCo record `nct07693751` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial in colorectal cancer, run by SOTIO Biotech a.s., now recruiting.

## Summary

A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07693751 by SOTIO Biotech a.s., with a registry enrolment figure of 100 participants, started 2026-08-12 and due to reach its primary completion in 2027-11-29. Interventions recorded: SOT109. Conditions listed: Colorectal Cancer (Locally Advanced or Metastatic). Primary outcome: Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT109; Part B: Optimal dose of SOT109 for subsequent clinical trials; Part B: Objective Response Rate (ORR) of SOT109. Colorectal eligibility wording from the registry: "* Direct (conjugated) bilirubin is within normal limits (≤ULN), and". Sites: Moldova, United States. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT07693751
- Phase: 1/2
- Setting: A First-in-human Phase 1/2 Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer
- Sponsor: SOTIO Biotech a.s.
- Enrolled: 100

## Sources

- ClinicalTrials.gov NCT07693751: https://clinicaltrials.gov/study/NCT07693751

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- companies: [SOTIO Biotech](https://onco.cc/companies/sotio/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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