Actively Recruiting
Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy
Led by West China Hospital · Updated on 2026-05-07
6
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed unresectable Stage III or Stage IV melanoma without prior systemic therapy
- At least one measurable lesion by RECIST v1.1 criteria
- At least one lesion suitable for intratumoral injection and radiotherapy (skin, subcutaneous tissue, superficial lymph nodes, or safely accessible visceral lesions) without prior radiotherapy unless progression documented
- Adequate hematologic function: ANC 212 1.5 x 1029/L, platelet count 212 90 x 1029/L, hemoglobin 212 90 g/L; no G-CSF, platelet transfusion, or EPO/RBC transfusion within 14 days before testing
- Adequate renal function: serum creatinine 2C 1.5 x upper limit of normal (ULN) or creatinine clearance 212 50 mL/min (Cockcroft-Gault formula)
- Adequate hepatic function: total bilirubin 2C 1.5 x ULN (up to 3.0 x ULN with Gilbert's Syndrome or liver metastases); AST, ALT, ALP 2C 2.5 x ULN (up to 5.0 x ULN for liver or bone metastases); serum albumin 212 2.8 g/dL
- Coagulation within normal limits: INR/PT and aPTT 2C 1.5 x ULN
- Cardiac function: left ventricular ejection fraction (LVEF) 212 50%
- Anticipated survival time of at least 16 weeks
- Agreement to use highly effective contraception during the trial and for 12 months after last treatment dose
- Willingness to voluntarily participate, sign informed consent, comply with study procedures, and cooperate with follow-up
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Known allergy to recombinant humanized anti-PD-1 monoclonal antibodies or components
- Active skin breakdown, infection, ulceration, necrosis, bleeding at injection site, or high risk of hollow organ perforation
- Allergy or intolerance to Au-TMP active ingredients, excipients, or similar compounds
- Presence of driver mutations (e.g., BRAF V600E/K, c-KIT, NRAS) with approved targeted therapies available as first-line treatment
- Ocular (uveal) or mucosal melanoma
- Receipt of other anti-tumor therapies or clinical trial participation within 4 weeks before treatment; failure to recover from prior toxicities (except Grade 2 alopecia and Grade 1 neurotoxicity)
- Pregnant or breastfeeding women
- Positive for HIV or HCV; Hepatitis B positive patients must have negative HBV DNA test (<500 IU/mL)
- History of active tuberculosis
- Active autoimmune disease requiring systemic treatment in past 2 years (except replacement therapy for thyroid, insulin, or adrenal/pituitary insufficiency)
- Serious uncontrolled medical conditions including uncontrolled diabetes, interstitial lung disease, NYHA Class III/IV heart failure, severe arrhythmias, recent myocardial infarction or cerebrovascular accident within 6 months
- Active CNS or leptomeningeal metastases; stable treated brain metastases allowed if no progression for 8 weeks and no immunosuppressive corticosteroids >10 mg prednisone equivalent for 2 weeks
- Receipt of hematopoietic stimulants (e.g., G-CSF, EPO) within 2 weeks prior to treatment
- Receipt of live vaccines within 4 weeks prior to treatment
- Major surgery (excluding diagnostic) within 4 weeks prior to treatment
- History of psychiatric disorders or persistent substance abuse
- Other malignancies within past 5 years except successfully treated localized cancers
- Any acute or chronic medical or psychiatric condition or abnormal labs increasing risk or interfering with study
- Any condition not in the participant's best interest
AI-Screening
AI-Powered Screening
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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
Research Team
X
Xingchen Peng, Professor
CONTACT
Y
Yuting Yan, Doctor
CONTACT
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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