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 study is testing Auger Molecular Therapy (AMT) — a type of targeted radiation therapy — for patients with malignant skin lesions (cutaneous metastases) from various types of advanced cancers including head and neck, breast, gastrointestinal, pancreatic, liver, endometrial, and prostate cancers. These skin lesions are often painful and difficult to treat. AMT uses a radioactive compound that targets cancer cells directly, delivering radiation from very short distances to minimize harm to surrounding healthy tissue. Participants receive the therapy applied to their skin lesions in outpatient sessions. The study measures how well the lesions respond and monitors for side effects. You may be eligible if: - You are 18 years or older - You have histologically confirmed advanced cancer (head/neck, breast, GI, pancreatic, liver, endometrial, or prostate cancer) - You have malignant skin lesions from metastasis or tumor invasion that fit within the treatment applicator (6 cm diameter) - The lesion is 0.7 cm or less in thickness - Your ECOG performance status is 3 or less You may NOT be eligible if: - You have a connective tissue disease or known radiation sensitivity syndrome - The lesion is on the eyelid, eye, genitalia, lip, or near the carotid artery - You are HIV positive - You are pregnant or breastfeeding - You are taking therapeutic anticoagulants Talk to your doctor to see if this trial is right for you.

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