drugset / Trial / NCT04807257

Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment

NCT04807257 ↗

Phase 1/2 Recruiting 18 enrolled NanoRay Biotech Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a first-in-human, single-arm, open-label, dose escalating study to determine the safety and the recommended maximum tolerated dose of the AMT in subjects with malignant cutaneous lesions. AMT is a combination therapy of a drug (IUdR) and a device (AUTRON Therapy System). IUdR is an iodinated thymidine analogue that is preferentially incorporated into DNA in rapid growing cells. The AUTRON Therapy System generates characteristic X-Ray photons around 33.4 keV, matching the K-edge energy of Iodine (33.17 keV), which can efficiently induce Auger electron emissions from IUdR in cancer DNA, resulting in extensive DNA damage and cancer cell death.

Timeline

Start
2024-08-05
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Iododeoxyuridine Unknown 2.83 ml Intrathecal
Subject Iododeoxyuridine Unknown 5.65 ml Intrathecal
Subject Iododeoxyuridine Unknown 7.07 ml Intrathecal

Indications

No indication recorded.