Clinical Research Directory

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.

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.