drugset
drugset / Trial / NCT05845450

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

NCT05845450 ↗

Phase 2 Recruiting 197 enrolled Gruppo Oncologico del Nord-Ovest
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.

Timeline

Start
2023-05-11
Primary completion
2026-05
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amivantamab Monoclonal antibody 1600 mg Subcutaneous
Subject Amivantamab Monoclonal antibody 2240 mg Subcutaneous
Subject Balstilimab Monoclonal antibody 3 mg/kg Intravenous
Subject Balstilimab Monoclonal antibody 240 mg Intravenous
Subject Botensilimab Monoclonal antibody 1 mg/kg Intravenous
Subject Botensilimab Monoclonal antibody 75 mg Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous
Subject Sotorasib Small molecule 960 mg Oral
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous
Subject Vorbipiprant Small molecule 90 mg —

Indications

colorectal carcinoma