Safety and Tolerability of Au-TMP Nanoparticles Combined With Radiotherapy and Toripalimab for Advanced Melanoma

What this Trial Is About

Advanced melanoma is a very aggressive cancer that often resists standard radiotherapy and single immunotherapy treatments. Researchers are studying a new treatment approach combining a melanoma-specific gold nanoparticle called Au-TMP with radiotherapy and anti-PD-1 immunotherapy. This Phase 1a trial aims to evaluate the safety and tolerability of this combination in patients with advanced melanoma. Participants receive a single injection of Au-TMP directly into a tumor, guided by ultrasound or CT scan. After this, they undergo fractionated radiotherapy totaling 30 Gy over 5 sessions, followed by systemic treatment with Toripalimab, an anti-PD-1 antibody given every two weeks. This sequence is designed to amplify radiation effects and help the immune system attack the tumor. During the study, participants will be closely monitored for side effects and dose-limiting toxicities up to 28 days after treatment, with additional safety assessments up to 12 months. Researchers will also measure drug levels in the blood and track tumor response for up to one year. The study includes thorough lab tests, imaging, and follow-ups to evaluate safety, tolerability, and preliminary effectiveness of the combined treatment.

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