Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment
Recruiting
Phase 1
Phase 2
Interventional Study
Malignant Fungating Wound
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- NanoRay Biotech Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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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 dis…
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