drugset / Trial / NCT04807257
Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.