drugset / Trial / NCT06280690

SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia

NCT06280690 ↗

Phase 2 Unknown 20 enrolled Leiden University Medical Center
Non-randomizedSequentialOpen-labelDiagnostic

Summary

This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101.

Timeline

Start
2024-01-31
Primary completion
2025-04-30
Completion
2025-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SGM-101 Monoclonal antibody 5 mg —
Subject SGM-101 Monoclonal antibody 10 mg —