Clinical Research Directory

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

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.

Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma

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.