Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma

Study Purpose

This device phase I/II, first in human, early feasibility study (EFS), open-label, single-arm trial aims to evaluate the safety, tolerability, and preliminary efficacy of Gold Nanorod (GNR)-enabled sub-ablative targeted hyperthermia therapy (THT) in patients with unresectable stage 3C/3D/4M1 cutaneous metastatic malignant melanoma that have failed to respond to systemic checkpoint and localized intra-tumoral immunotherapy. The study will involve up to 10 participants with stable or progressive cutaneous and/or subcutaneous skin lesions (Immune Stable Disease (iSD) or Immune Confirmed/Unconfirmed Progressive Disease (iCPD/iUPD)). GNRs, when administered via intra-tumoral injection and activated by NIR light, generate localized heat through a process called THT. This approach selectively targets tumor cells while minimizing damage to surrounding healthy tissue. In this study, 10 participants will receive two THT treatments spaced 7 days apart. The primary objective of this study is to assess the safety and tolerability of THT treatment.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 16 years of age or older; 2. Participants with histologically or cytologically confirmed stage 3C/3D/4M1 advanced or cutaneous metastatic melanoma, with measurable disease by iRECIST 1.1 criteria, including any number of cutaneous lesions; 3. Present a visible and accessible primary tumor or metastatic deposit (any site) that has not been surgically removed; 4. Present target tumors of ≤2.5 cm in diameter; 5. Participants must have received and failed systemic and local intra-tumoral therapy at least one prior standard therapy, including immune checkpoint inhibitors (e.g., anti- PD1 or anti-CTLA-4), and failed local intra-tumoral IL-2 treatment. Failed response to treatment will be categorized according to iRECIST guidelines. Patients who have: a) Immune partial response (iPR): At least a 30% decrease in the sum of diameters of target lesions compared to baseline, no progression of non-target lesions, No new lesions; or b) Immune Stable Disease (iSD): Neither sufficient reduction to qualify for iPR nor sufficient increase to qualify for iCPD (immune confirmed progressive disease), no new lesions; or c) Immune Unconfirmed Progressive Disease (iUPD): At least a 20% increase in the sum of diameters of target lesions, taking the smallest sum on study as the reference, appearance of new lesions, iUPD needs confirmation after at least 4 weeks; if confirmed, it becomes iCPD; or d) Immune Confirmed Progressive Disease (iCPD): iUPD must be confirmed in a follow-up assessment (minimum of 4 weeks after initial iUPD), if progressive disease (increase in lesion size or additional new lesions) is still evident upon re-evaluation, iCPD is confirmed. 6. Participants must agree to discontinue treatment with local intralesional immunotherapies during the study, with resumption after completion of the trial; 7. ECOG Performance Status: ≤1; 8. Life expectancy: ≥6 months; 9. Participants able and willing to provide written informed consent and comply with the trial protocol. 10. Either BRAF positive (BRAF+) or BRAF negative (BRAF-).

Exclusion criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the study. 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; 2. Any infection requiring systemic therapy or other concurrent medical conditions (e.g., hepatitis B, hepatitis C, HIV) that would interfere with the study; 3. Myocardial infarction or stroke within the past 6 months, uncontrolled angina, or significant arrhythmia; 4. Participants receiving blood thinners as part of therapeutic anticoagulation therapy; 5. 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); 6. Participation in another clinical trial involving an investigational product/device within 30 days prior to screening; 7. Any condition that would impede compliance with study procedures; 8. Participants with a known allergy to gold of any kind; 9. Participants who are unable to tolerate cutaneous injections for any reason will not be eligible; 10. Participants with a known allergy to injectable local analgesics; 11. Participants with ocular melanoma or melanoma involving periorbital skin.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06870994
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sona Nanotech Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lucy K Helyer, MD
Principal Investigator Affiliation	Nova Scotia Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Metastatic Melanoma

Arms & Interventions

Arms

Experimental: Targeted Hyperthermia Therapy

Interventions

Device: - Targeted Hyperthermia Therapy

Intra-tumoral gold nanorods (SivaRods) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Carman Giacomantonio, MD

[email protected]

902-473-6177

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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