Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment

Launched by NANORAY BIOTECH CO., LTD. · Mar 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Auger Molecular Therapy (AMT) for patients with malignant cutaneous lesions, which are harmful skin growths caused by cancer. The goal of the trial is to test the safety of AMT and to find out the highest dose that can be given without causing serious side effects. AMT combines a special drug that targets rapidly growing cancer cells with a device that helps deliver this treatment directly to the cancerous area. This trial is currently recruiting participants aged 18 and older who have specific types of advanced cancers and certain qualifying skin lesions.

To participate, individuals should have confirmed advanced cancers like head and neck, breast, or gastrointestinal cancers with skin lesions that can be treated using the study’s equipment. Participants will be monitored closely during the trial to ensure their safety and to see how well the treatment works. It’s important to know that if someone is already undergoing other cancer treatments, they may still be eligible for this trial as long as their condition allows it. Overall, this trial aims to explore a promising new way to treat certain cancers that affect the skin, providing hope for patients facing these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years.
• • 2. 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.
• • 3. Cutaneous lesion(s) that is (are) from distant metastasis or direct invasion of tumor types as above.
• • 4. 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).
• • 5. The subject must have malignant cutaneous lesion thickness of ≤0.7 cm
• • 6. The subject must have measurable disease by the square grid methods using transparency wound dressing or projection light.
• • 7. ECOG Performance Status ≤ 3.
• 8. 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.
• • 9. Provided written informed consent in accordance with all applicable regulations and followed the study procedures.
• • 10. Subjects are capable of understanding the investigational nature, potential risks and benefits of the study.
• • 11. 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 Criteria:
• • 1. Restless patients who are unable to lie or sit in a cast for 25 mins.
• • 2. Hypersensitive to the study drug.
• • 3. Patients with connective tissue diseases
• • 4. Patients with known syndromes associated with radiation sensitivity.
• • 5. Patients with prior radiotherapy to the area which could compromise safety of additional treatments.
• • 6. Lesion(s) that is derived from localized and curable tumor(s).
• • 7. Lesion(s) with friable surface or necrotic changes.
• • 8. 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.
• • 9. Uncontrolled intercurrent illness, such as severe infection, symptomatic heart disease, etc.
• • 10. Concomitant treatment with therapeutic anticoagulants.
• • 11. Receiving or requiring immunosuppressive therapies.
• • 12. Human immunodeficiency virus (HIV) infection.
• • 13. Any underlying medical conditions, which in the opinion of the investigator, would make the study hazardous or make it difficult to monitor adverse effects.
• • 14. Participation in any investigational drug study within 4 weeks prior to screening.
• • 15. 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.
• • 16. 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.
• • 17. Patients with a QTcF \>470 ms on screening.