Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04807257
Status:
RECRUITING
Last Update Posted:
2022-09-29
First Post:
2021-03-17
Brief Title:
Auger Molecular Therapy AMT for Malignant Cutaneous Lesions Treatment
Sponsor:
Redacted
Organization:
Redacted
Study Overview
Official Title:
A First-in-Human Study of Auger Molecular Therapy AMT in Patients With Malignant Cutaneous Lesions From Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
True
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 334 keV matching the K-edge energy of Iodine 3317 keV which can efficiently induce Auger electron emissions from IUdR in cancer DNA resulting in extensive DNA damage and cancer cell death
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 334 keV matching the K-edge energy of Iodine 3317 keV which can efficiently induce Auger electron emissions from IUdR in cancer DNA resulting in extensive DNA damage and cancer cell death
Detailed Description:
NanoRay Biotech is developing a novel investigational therapeutic system called Auger Molecular Therapy AMT which consists of a drug Iododeoxyuridine IUdR and a medical device AUTRON Therapy System intended for the palliative treatment of malignant cutaneous lesions IUdR is an iodinated analogue of deoxyuridine which can be incorporated into DNA of cancer cells because it is a thymidine analogue The AUTRON Therapy System is a complete standalone low energy X-Ray radiation source 80 kVp 100 μA intended for local irradiation The AUTRON Therapy System contains a novel design of transmission type X-Ray tube which allows electron beams to pass through the metal target and generates characteristic X-Ray similar to synchrotron radiation
The combination product is intended to induce Auger effect to augment the damage on tumor cells while lowering the adverse effect on normal cells IUdR is an iodinated thymidine analogue that is preferentially incorporated into DNA in rapid growing cells such as cancer cells after administration The AUTRON Therapy System generates characteristic X-Ray photons around 334 keV matching the K-edge energy of Iodine 3317 keV which can efficiently induce emissions of Auger electrons when hitting the Iodine atoms on IUdR in cancer DNA resulting in extensive DNA damage and cancer cell death Furthermore the characteristic X-Ray photons generated by the AUTRON Therapy System have a low penetration rate in biological materials which give the maximum dose on superficial lesions and much reduced dose on peripheral or deep normal tissues fitting the need on the management of malignant cutaneous lesions
The combination product is intended to induce Auger effect to augment the damage on tumor cells while lowering the adverse effect on normal cells IUdR is an iodinated thymidine analogue that is preferentially incorporated into DNA in rapid growing cells such as cancer cells after administration The AUTRON Therapy System generates characteristic X-Ray photons around 334 keV matching the K-edge energy of Iodine 3317 keV which can efficiently induce emissions of Auger electrons when hitting the Iodine atoms on IUdR in cancer DNA resulting in extensive DNA damage and cancer cell death Furthermore the characteristic X-Ray photons generated by the AUTRON Therapy System have a low penetration rate in biological materials which give the maximum dose on superficial lesions and much reduced dose on peripheral or deep normal tissues fitting the need on the management of malignant cutaneous lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None