MedTrace Logo

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

NCT07562841 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Au-TMP

A single intratumoral injection of Au-TMP (at concentrations of 50 mg/mL using escalating dose levels of 5% or 10% of tumor volume)

RADIATION

Fractionated Radiotherapy (RT)

Local radiotherapy (RT) delivered to the injected tumor lesion, with a total dose of 30 Gy delivered in 5 fractions (6 Gy per fraction).

DRUG

Toripalimab

Administration of Toripalimab (anti-PD-1 antibody) at a fixed dose of 240 mg, administered every 2 weeks (Q2W).

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562841 on ClinicalTrials.gov