Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment
Trial Parameters
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 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.
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