NCT06894407

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

Intra-tumoral Targeted Hyperthermic Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma in Patients with Targetable Cutaneous And/or Sub-cutaneous Tumors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sona Nanotech Inc · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cutaneous Metastatic Melanoma

Interventions

Type	Name	Description
DEVICE	Device: Targeted Hyperthermia Therapy	Intra-tumoral gold nanorods (SivaRods) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-03-25
• Last updated: 2025-03-26