Intratumoral Targeted Hyperthermia Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma

This phase I/II device clinical trial investigates the safety and efficacy of GNR-mediated THT in patients with stage 3C/3D/4M1 cutaneous metastatic melanoma unresponsive to systemic checkpoint immunotherapy or in patients who have contraindications to systemic immunotherapy. The primary objective of the study is to evaluate the safety of THT treatment, with secondary objectives focused on tumor response to treatment. Patients will receive intra-tumoral GNR injections, followed by NIR light therapy to induce mild hyperthermia, with intra-tumoral temperatures monitored to achieve a target range of 42°C to 48°C. The trial aims to establish a safe, effective dose of GNRs for THT therapy for cutaneous metastatic melanoma treatment and explore the potential for its localized tumor destruction.

NCT Number	NCT06894407
Lead Sponsor	Sona Nanotech Inc
Conditions	Cutaneous Metastatic Melanoma
Enrollment	10 participants
Start Date	2025-05
Primary Completion	2026-04 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2025-03-26