Status:
RECRUITING
Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment
Lead Sponsor:
NanoRay Biotech Co., Ltd.
Conditions:
Malignant Fungating Wound
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 S...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histologically confirmed diagnosis of advanced head and neck cancers, breast cancers, gastrointestinal cancers, pancreatic cancers, gallbladder cancer, liver cancers, endometrial cancer, and/or prostate cancers.
- Cutaneous lesion(s) that is (are) from distant metastasis or direct invasion of tumor types as above.
- The size of lesion to be treated can be covered by the irradiation Applicator (a circle in the diameter of 6 cm, around 28.27 cm2 in surface area).
- The subject must have malignant cutaneous lesion thickness of ≤0.7 cm
- The subject must have measurable disease by the square grid methods using transparency wound dressing or projection light.
- ECOG Performance Status ≤ 3.
- Adequate organ functions determined within 4 weeks prior to enrollment defined as:
- Hematologic: (ANC) ≥ 1.0 × 109/L; Hemoglobin ≥ 9 g/dL; Platelet count ≥ 100 × 109/L; PT or PTT ≤ 1.5 ×upper limit of normal value (ULN).
- Hepatic function: bilirubin \< 2 × ULN, and AST and ALT \< 3 × ULN.
- Renal Function: creatinine clearance \> 50 mL/min.
- Provided written informed consent in accordance with all applicable regulations and followed the study procedures.
- Subjects are capable of understanding the investigational nature, potential risks and benefits of the study.
- A subject who is receiving concurrent systemic therapy, including chemotherapy and immunotherapy, can be recruited without ceasing the systemic therapy. However, the subject should be discontinued from the trial if the subject requires treatment with a new systemic therapy.
Exclusion
- Restless patients who are unable to lie or sit in a cast for 25 mins.
- Hypersensitive to the study drug.
- Patients with connective tissue diseases
- Patients with known syndromes associated with radiation sensitivity.
- Patients with prior radiotherapy to the area which could compromise safety of additional treatments.
- Lesion(s) that is derived from localized and curable tumor(s).
- Lesion(s) with friable surface or necrotic changes.
- Lesion(s) locates on the eyelid, the eye, the genitalia, the lip and near the carotid artery that might expose the patients in a great risk when receiving irradiation.
- Uncontrolled intercurrent illness, such as severe infection, symptomatic heart disease, etc.
- Concomitant treatment with therapeutic anticoagulants.
- Receiving or requiring immunosuppressive therapies.
- Human immunodeficiency virus (HIV) infection.
- Any underlying medical conditions, which in the opinion of the investigator, would make the study hazardous or make it difficult to monitor adverse effects.
- Participation in any investigational drug study within 4 weeks prior to screening.
- Pregnant or breast-feeding female. Note: Confirmation that women of child- bearing potential are not pregnant. A negative serum or urine β-human chorionic gonadotropin (β-hCG) pregnancy test result is to be obtained during the screening period.
- Fertile males and females who are unwilling to employ adequate means of contraception (e.g., condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches, or intrauterine device) during the study and through 4 to 6 months after the study.
- Patients with a QTcF \>470 ms on screening.
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04807257
Start Date
August 5 2024
End Date
December 31 2026
Last Update
July 24 2024
Active Locations (1)
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1
Taipei Medical University Hospital
Taipei, Taiwan, 110