Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy

Advanced melanoma is a highly aggressive malignancy that frequently exhibits resistance to conventional radiotherapy and single-agent immunotherapy. This study aims to evaluate the safety and tolerability of an innovative melanoma-specific aggregable gold nanosystem (Au-TMP) in patients with advanced melanoma. This single-arm, open-label, Phase 1a clinical trial utilizes a dose-escalation design, where participants receive a single intratumoral injection of Au-TMP followed by sequential radiotherapy and Toripalimab (anti-PD-1) treatment. This trial aims at assessing the safety of intratumoral injection of Au-TMP and radiotherapy in combination with anti-PD-1 therapy.

NCT Number	NCT07562841
Lead Sponsor	West China Hospital
Conditions	Advanced Melanoma
Enrollment	6 participants
Start Date	2026-04-28
Primary Completion	2028-04-30 (estimated)
Study Completion	2029-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-07