NCT06894407Completed
Intratumoral Targeted Hyperthermia Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma
Intratumoral Targeted Hyperthermic Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma in Patients With Targetable Cutaneous and/or Sub-cutaneous Tumors
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This first-in-human device clinical trial investigates the safety and feasibility of GNR-mediated THT in patients with stage 3C/3D/4M1 cutaneous metastatic melanoma unresponsive to systemic to PD-1 immune checkpoint immunotherapy or in patients who have contraindications to systemic immunotherapy. The primary objective of the study is to evaluate the safety and feasibility of THT treatment, with secondary objectives focused on tumor response to treatment. Patients will receive intratumoral GNR injections, followed by NIR light therapy to induce mild hyperthermia, with intratumoral temperatures monitored to achieve a target range of 42°C to 48°C.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 18 Mar 2025
- Start date
- 3 Jul 2025
- Primary completion date
- 26 Sept 2025
- Lead sponsor
- Sona Nanotech Inc
- Diseases
- Melanoma
- NCT number
- NCT06894407
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 3 Jul 2025 to the primary completion date, 26 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women of childbearing potential must have a negative pregnancy test within 72 hours prior to enrollment and agree to use adequate contraception throughout the study
- Any infection requiring systemic therapy or other concurrent medical conditions (e.g., hepatitis B, hepatitis C, HIV) that would interfere with the study
- Participants receiving blood thinners as part of therapeutic anticoagulation therapy
- Participation in another clinical trial involving an investigational product/device within 30 days prior to screening
Other illness
- Myocardial infarction or stroke within the past 6 months, uncontrolled angina, or significant arrhythmia
- Any severe or uncontrolled comorbid condition that, in the investigator's opinion, would pose excessive risk to the participants (e.g., immunodeficiencies, severe hypertension, uncontrolled diabetes, liver failure)
- Any condition that would impede compliance with study procedures
- Participants with a known allergy to gold of any kind
- Participants with a known allergy to injectable local analgesics
Other
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Participants who are unable to tolerate cutaneous injections for any reason will not be eligible
- Participants with ocular melanoma or melanoma involving periorbital skin.
Who the study is looking for
- 18 years of age or older
- Participants with histologically or cytologically confirmed stage 3C/3D/4M1 advanced or cutaneous metastatic melanoma, with measurable disease by standard histological methods (not iRECIST) including any number of cutaneous lesions
- Present a visible and accessible primary tumor or metastatic deposit (any site) that has not been surgically removed
- Present target tumors of 0.5 -2.5 cm in diameter
- Participants must have received and failed (progressed) following at least one prior standard therapy, including immune checkpoint inhibitors (e.g., anti- PD1 or anti-CTLA-4).
- Response is determined by clinical assessment and photo documentation.
- ECOG Performance Status: 0-1
- Life expectancy: ≥6 months
- Participants able and willing to provide written informed consent and comply with the trial protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bradford Hill Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.