Malignant Fungating WoundPhase 1/2NCT04807257
Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment
A Phase 1/2 study testing Auger Molecular Therapy (AMT) in people with Malignant Fungating Wound, run by NanoRay Biotech Co., Ltd. at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Fungating Wound
- What is being tested?
- Auger Molecular Therapy (AMT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2024to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- 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.
- Cutaneous lesion(s) that is (are) from distant metastasis or direct invasion of tumor types as above.
- 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).
- The subject must have malignant cutaneous lesion thickness of ≤0.7 cm
- The subject must have measurable disease by the square grid methods using transparency wound dressing or projection light.
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- ECOG Performance Status ≤ 3.
- 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.
- Provided written informed consent in accordance with all applicable regulations and followed the study procedures.
- Subjects are capable of understanding the investigational nature, potential risks and benefits of the study.
- 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.
Who cannot join
- Restless patients who are unable to lie or sit in a cast for 25 mins.
- Hypersensitive to the study drug.
- Patients with connective tissue diseases
- Patients with known syndromes associated with radiation sensitivity.
- Patients with prior radiotherapy to the area which could compromise safety of additional treatments.
- Lesion(s) that is derived from localized and curable tumor(s).
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- Lesion(s) with friable surface or necrotic changes.
- 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.
- Uncontrolled intercurrent illness, such as severe infection, symptomatic heart disease, etc.
- Concomitant treatment with therapeutic anticoagulants.
- Receiving or requiring immunosuppressive therapies.
- Human immunodeficiency virus (HIV) infection.
- Any underlying medical conditions, which in the opinion of the investigator, would make the study hazardous or make it difficult to monitor adverse effects.
- Participation in any investigational drug study within 4 weeks prior to screening.
- 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.
- 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.
- Patients with a QTcF >470 ms on screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Feng-Yi Chou, MS, +886-2-2737-2181 ext. 7602, 926115@h.tmu.edu.tw
Jeng-Fong Chiou, MD, PhD
About this study
Official title: A First-in-Human Study of Auger Molecular Therapy (AMT) in Patients With Malignant Cutaneous Lesions From Advanced Solid Tumors
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.
Read the detailed description
NanoRay Biotech is developing a novel investigational therapeutic system called Auger Molecular Therapy (AMT), which consists of a drug, Iododeoxyuridine (IUdR), and a medical device, AUTRON Therapy System, intended for the palliative treatment of malignant cutaneous lesions. IUdR is an iodinated analogue of deoxyuridine, which can be incorporated into DNA of cancer cells because it is a thymidine analogue. The AUTRON Therapy System is a complete, standalone low energy X-Ray radiation source (80 kVp, 100 μA) intended for local irradiation. The AUTRON Therapy System contains a novel design of transmission type X-Ray tube, which allows electron beams to pass through the metal target and generates characteristic X-Ray similar to synchrotron radiation.
The combination product is intended to induce Auger effect to augment the damage on tumor cells, while lowering the adverse effect on normal cells. IUdR is an iodinated thymidine analogue that is preferentially incorporated into DNA in rapid growing cells (such as cancer cells) after administration. 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 emissions of Auger electrons when hitting the Iodine atoms on IUdR in cancer DNA, resulting in extensive DNA damage and cancer cell death. Furthermore, the characteristic X-Ray photons generated by the AUTRON Therapy System have a low penetration rate in biological materials, which give the maximum dose on superficial lesions and much reduced dose on peripheral or deep normal tissues, fitting the need on the management of malignant cutaneous lesions.
- Conditions
- Malignant Fungating Wound
- Being tested
- Auger Molecular Therapy (AMT)
- Keywords
- Malignant fungating wound, Malignant wound, Malignant cutaneous lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auger Molecular Therapy (AMT)Combination product
The AMT consists of intratumorally delivered IUdR and local irradiation via AUTRON Therapy System.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Combination Product: Auger Molecular Therapy (AMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion severity
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.
Measured: 56 weeks from Day -1 predose
Improvement of quality of life
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.
Measured: 8 weeks from Day -1 predose
Assess the drug safety during treatment
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).
Measured: 4 weeks of treatment cycle
Assess the drug safety post-treatment
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).
Measured: 4 weeks post treatment
Local control of lesion
The lesion condition change is evaluated by CT before and after treatment.
Measured: 12 weeks
Secondary outcomes (1)
Systemic immune response
Evaluated by changes in composition of peripheral lymphocytes in patient blood samples.
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start5 Aug 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Fungating WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoRay Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807257
- Sponsor's protocol ID
- AMT-NR-33
- Status last verified
- Jul 2024
- First submitted
- 17 Mar 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of Auger Molecular Therapy (AMT) in Patients With Malignant Cutaneous Lesions From Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04807257
- Acronym / sponsor ID
- AMT-NR-33
- Conditions
- Malignant Fungating Wound
- Keywords
- Malignant fungating wound, Malignant wound, Malignant cutaneous lesion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- NanoRay Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
NanoRay Biotech is developing a novel investigational therapeutic system called Auger Molecular Therapy (AMT), which consists of a drug, Iododeoxyuridine (IUdR), and a medical device, AUTRON Therapy System, intended for the palliative treatment of malignant cutaneous lesions. IUdR is an iodinated analogue of deoxyuridine, which can be incorporated into DNA of cancer cells because it is a thymidine analogue. The AUTRON Therapy System is a complete, standalone low energy X-Ray radiation source (80 kVp, 100 μA) intended for local irradiation. The AUTRON Therapy System contains a novel design of transmission type X-Ray tube, which allows electron beams to pass through the metal target and generates characteristic X-Ray similar to synchrotron radiation.
The combination product is intended to induce Auger effect to augment the damage on tumor cells, while lowering the adverse effect on normal cells. IUdR is an iodinated thymidine analogue that is preferentially incorporated into DNA in rapid growing cells (such as cancer cells) after administration. 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 emissions of Auger electrons when hitting the Iodine atoms on IUdR in cancer DNA, resulting in extensive DNA damage and cancer cell death. Furthermore, the characteristic X-Ray photons generated by the AUTRON Therapy System have a low penetration rate in biological materials, which give the maximum dose on superficial lesions and much reduced dose on peripheral or deep normal tissues, fitting the need on the management of malignant cutaneous lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Malignant Cutaneous Lesions from Advanced Solid Tumors | Experimental | Combination Product: Auger Molecular Therapy (AMT)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years.
- 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.
- Cutaneous lesion(s) that is (are) from distant metastasis or direct invasion of tumor types as above.
- 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).
- The subject must have malignant cutaneous lesion thickness of ≤0.7 cm
Key exclusion criteria (17 listed)
- Restless patients who are unable to lie or sit in a cast for 25 mins.
- Hypersensitive to the study drug.
- Patients with connective tissue diseases
- Patients with known syndromes associated with radiation sensitivity.
- Patients with prior radiotherapy to the area which could compromise safety of additional treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auger Molecular Therapy (AMT)The AMT consists of intratumorally delivered IUdR and local irradiation via AUTRON Therapy System. | Combination product | Patients with Malignant Cutaneous Lesions from Advanced Solid Tumors |
Primary outcome
Lesion severity
Time frame: 56 weeks from Day -1 predose
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.
Improvement of quality of life
Time frame: 8 weeks from Day -1 predose
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.
Assess the drug safety during treatment
Time frame: 4 weeks of treatment cycle
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).
Assess the drug safety post-treatment
Time frame: 4 weeks post treatment
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).
Local control of lesion
Time frame: 12 weeks
The lesion condition change is evaluated by CT before and after treatment.
1 secondary outcome
Systemic immune response
Time frame: 56 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- The principal of Auger Molecular TherapyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Auger Molecular Therapy (AMT) in people with Malignant Fungating Wound, run by NanoRay Biotech Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Lee, MS (+ 886 2 3393 1388 ext. 8820, irene.lee@qps-taiwan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion severity (time frame: 56 weeks from Day -1 predose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.