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RECRUITING
NCT04807257
PHASE1/PHASE2

Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment

Sponsor: NanoRay Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A First-in-Human Study of Auger Molecular Therapy (AMT) in Patients With Malignant Cutaneous Lesions From Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-08-05

Completion Date

2026-12-31

Last Updated

2024-07-24

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Auger Molecular Therapy (AMT)

The AMT consists of intratumorally delivered IUdR and local irradiation via AUTRON Therapy System.

Locations (1)

Taipei Medical University Hospital

Taipei, Taiwan