Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID07562841

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

Led by West China Hospital · Updated on 2026-05-07

6

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG performance status of 0 or 1
  • Histologically confirmed unresectable Stage III or IV melanoma without prior systemic therapy
  • At least one measurable lesion per RECIST v1.1
  • At least one lesion suitable for intratumoral injection and radiotherapy
  • Adequate blood counts and organ function within 7 days prior to treatment
  • Anticipated survival of at least 16 weeks
  • Agreement to use effective contraception during and for 12 months after the trial
  • Willingness to participate, sign consent, and comply with follow-up
Not Eligible

You will not qualify if you...

  • Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
  • Known allergy to anti-PD-1 antibodies or Au-TMP components
  • Active skin breakdown, infection, ulceration, or bleeding at injection site
  • Presence of driver mutations with approved first-line targeted therapies
  • Ocular (uveal) or mucosal melanoma
  • Use of other anti-tumor therapies or clinical trial participation within 4 weeks
  • Pregnant or breastfeeding women
  • Positive HIV or Hepatitis C; certain Hepatitis B conditions
  • History of active tuberculosis
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Serious uncontrolled medical conditions or recent major cardiac events
  • Active brain or leptomeningeal metastases unless stable and off high-dose steroids
  • Recent use of hematopoietic stimulants or live vaccines
  • Major surgery within 4 weeks prior to treatment
  • History of psychiatric disorders or substance abuse
  • Other malignancies within 5 years except certain localized treated cancers
  • Any condition increasing risk or interfering with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - At least 4 weeks with Toripalimab continued every 2 weeks thereafter up to 12 months or until disease progression or discontinuation

Participants receive a single intratumoral injection of Au-TMP, followed by local fractionated radiotherapy to the injected tumor, and systemic administration of Toripalimab every 2 weeks.

1 injection visit, 5 radiotherapy visits, and biweekly visits for Toripalimab administration

Follow-up

Duration - Up to 12 months

Participants are monitored for safety, adverse events, and treatment response for up to 12 months after the initial Au-TMP administration.

Regular visits scheduled for safety and response assessments

Trial Site Locations

Total: 2 locations

1

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Not Yet Recruiting

2

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

X

Xingchen Peng, Professor

Y

Yuting Yan, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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