RecruitingPhase 1Phase 2NCT04807257

Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment

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


Sponsor

NanoRay Biotech Co., Ltd.

Enrollment

18 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Auger Molecular Therapy (AMT) for people with malignant fungating wound. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTAuger 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

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NCT04807257