Treatment for malignant cutaneous lesions using Auger Molecular Therapy

A First-in-Human Study of Auger Molecular Therapy (AMT) in Patients With Malignant Cutaneous Lesions From Advanced Solid Tumors

This study is testing a new treatment called Auger Molecular Therapy to see if it can safely target and damage cancer cells in skin lesions while protecting healthy tissue.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NanoRay Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Taipei)
• Trial ID: NCT04807257 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and maximum tolerated dose of Auger Molecular Therapy (AMT) in patients with malignant cutaneous lesions. AMT combines the drug Iododeoxyuridine (IUdR) with the AUTRON Therapy System, which generates low-energy X-ray photons to induce DNA damage specifically in cancer cells. The study is a first-in-human, single-arm, open-label, dose-escalating approach aimed at determining the effectiveness of this novel treatment. Participants will receive localized irradiation to target their malignant lesions while minimizing damage to surrounding healthy tissue.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced cancers that have resulted in malignant cutaneous lesions.

Not a fit: Patients with lesions thicker than 0.7 cm or those with non-malignant conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new palliative treatment option for patients with advanced malignant cutaneous lesions.

How similar studies have performed: While this approach is novel, other studies using targeted therapies for cancer treatment have shown promising results.

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.

Where this trial is running

Taipei

• Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Irene Lee, MS

Conditions Malignant Fungating Wound; Malignant fungating wound; Malignant wound; Malignant cutaneous lesion