{"entity":{"id":"nct07693751","kind":"trial","name":"A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer","aka":[],"tldr":"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.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07693751","url":"https://clinicaltrials.gov/study/NCT07693751"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sotio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07693751/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"company":[{"id":"sotio","kind":"company","name":"SOTIO Biotech","route":"/companies/sotio/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}