Actively Recruiting
Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment
Led by NanoRay Biotech Co., Ltd. · Updated on 2024-07-24
18
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed advanced cancers of head and neck, breast, gastrointestinal, pancreatic, gallbladder, liver, endometrial, or prostate origin
- Malignant cutaneous lesion(s) from distant metastasis or direct tumor invasion
- Lesion size suitable to be covered by a 6 cm diameter irradiation applicator
- Malignant cutaneous lesion thickness of 0.7 cm or less
- Measurable disease using square grid method with transparency dressing or projection light
- ECOG Performance Status of 3 or less
- Adequate organ function within 4 weeks before enrollment, including hematologic, hepatic, and renal function criteria
- Provided written informed consent and can understand study risks and benefits
- May be receiving concurrent systemic therapy if no new systemic therapy is started during the trial
You will not qualify if you...
- Unable to lie or sit still for 25 minutes during treatment
- Hypersensitivity to the study drug
- Presence of connective tissue diseases
- Known syndromes associated with radiation sensitivity
- Prior radiotherapy in the treatment area affecting safety
- Lesions derived from localized and curable tumors
- Lesions with friable surface or necrotic changes
- Lesions located on eyelid, eye, genitalia, lip, or near carotid artery posing high irradiation risk
- Uncontrolled serious illnesses such as severe infection or symptomatic heart disease
- Use of therapeutic anticoagulants
- Receiving or requiring immunosuppressive therapies
- HIV infection
- Any medical condition deemed hazardous or complicating safety monitoring by investigator
- Participation in investigational drug studies within 4 weeks before screening
- Pregnant or breastfeeding females; women of childbearing potential must have negative pregnancy test
- Fertile males and females unwilling to use adequate contraception during and 4 to 6 months after the study
- QTcF greater than 470 ms on screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
I
Irene Lee, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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