Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04807257 | Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment | PHASE1 | RECRUITING | 18 | — | — | Aug 5, 2024 | Dec 31, 2026 | Jul 24, 2024 | 1 | Taiwan |
In this trial, local lesion assessment will be carried out by a simplified Modified Severity Weighted Assessment Tool (mSWAT) without %BSA parameter, since the AMT is applied only on local and single lesion. A local skin scoring by area with a multiplication by weighting factors of various lesion types (patch=1, plaque=2 and tumor=4) is applied for mSWAT evaluation.
The Taiwanese version of the McGill Quality of Life Questionnaire (MQOL) consists of 16 items, global QOL questions and open-ended questions allowing patients to self-report life events that have influenced their QOL. There are four parts in MQOL: physical symptoms (items 1-4), psychological well-being (items 5-8), existential well-being (items 9-14), and support issues (items 15 and 16). All of the response categories are based on a numerical scale of from 0 to 10. The all score will be divided into four parts and a high score indicates a better QOL.
Safety evaluation will be based on the percentage of subjects with dose-limiting toxicity (DLT), adverse events (AE), and serious adverse events (SAE). Toxicity will be classified by National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Safety evaluation will be based on the percentage of subjects with dose-limiting toxicity (DLT), adverse events (AE), and serious adverse events (SAE). Toxicity will be classified by National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
The lesion condition change is evaluated by CT before and after treatment.
| Arm | Type | Description |
|---|---|---|
| Patients with Malignant Cutaneous Lesions from Advanced Solid Tumors | EXPERIMENTAL | The IUdR, which is manufactured as lyophilized powder for injection, is dissolved by normal saline before use. There are three cohorts with escalating doses of IUdR starting from an injection dose of 0.1 mL per lesion surface area unit of 1 cm2 and if tolerated, escalate to 0.2 mL/cm2 and to 0.25 mL/cm2 as presented below. Meanwhile, the upper limit of total injection doses of IUdR in the 3 levels are 2.83, 5.65, and 7.07ml , which correspond to 0.059, 0.118, and 0.147 mg/kg for a 60 kg adult, respectively. The dose of AUTRON Therapy System irradiation for all 3 cohorts keeps fixed at 25 Gy over 5 days (5 Gy/day). |
| Name | Type | Description |
|---|---|---|
| Auger Molecular Therapy (AMT) | COMBINATION_PRODUCT | The AMT consists of intratumorally delivered IUdR and local irradiation via AUTRON Therapy System. |
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 dis...