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Advanced MelanomaPhase 1NCT07562841

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

A Phase 1 study testing Au-TMP, Fractionated Radiotherapy (RT) and Toripalimab in people with Advanced Melanoma, run by West China Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
Au-TMP, Fractionated Radiotherapy (RT) and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesChina
Study dates
28 Apr 2026to 30 Apr 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically confirmed unresectable Stage III or Stage IV melanoma without prior systemic therapy. Prior adjuvant or neoadjuvant therapy is permitted, provided it was completed at least 3 weeks before enrollment and all related adverse events (AEs) have resolved to baseline or NCI CTCAE v5.0 Grade ≤ 1.
  • Presence of at least one measurable lesion according to RECIST v1.1 criteria.
  • At least one lesion suitable for intratumoral injection and radiotherapy (located in the skin, subcutaneous tissue, superficial lymph nodes, or visceral lesions assessed as safe for access) that has not received prior radiotherapy (unless documented progression has occurred).
  • Adequate hematologic and organ function within 7 days prior to the first dose, including:
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  • Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 90 × 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L. (No Granulocyte-Colony Stimulating Factor (G-CSF), platelet transfusion, or Erythropoietin (EPO)/Red Blood Cell (RBC) transfusion within 14 days prior to testing).
  • Renal Function: Serum creatinine (Cr) ≤ 1.5 × Upper Limit of Normal (ULN), or calculated creatinine clearance (Ccr) ≥ 50 mL/min using the Cockcroft-Gault formula.
  • Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN (≤ 3.0 × ULN for patients with Gilbert's Syndrome or liver metastases); Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5 × ULN (≤ 5.0 × ULN for patients with documented liver or bone metastases); Serum albumin ≥ 2.8 g/dL.
  • Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN.
  • Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
  • Anticipated survival time ≥ 16 weeks.
  • Agreement to use highly effective contraception methods during the trial and for 12 months after the last dose of treatment.
  • Voluntarily participate in the study, sign the Informed Consent Form (ICF), demonstrate good compliance, and be willing to cooperate with follow-up.

Who cannot join

  • Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
  • Known hypersensitivity to recombinant humanized anti-PD-1 monoclonal antibodies or any of their components.
  • Active skin breakdown, infection, ulceration, necrosis, bleeding at the injection site, or a high risk of hollow organ perforation.
  • Known allergy or intolerance to Au-TMP active ingredients, excipients, or similar compounds.
  • Presence of known driver mutations (e.g., BRAF V600E/K, c-KIT, NRAS) for which targeted therapies are already approved and available as first-line treatment.
  • Ocular (uveal) or mucosal melanoma.
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  • Receipt of other anti-tumor therapies (including corticosteroids or immunotherapy) or participation in other clinical trials within 4 weeks before treatment initiation; failure to recover from toxicities of prior therapies (except Grade 2 alopecia and Grade 1 neurotoxicity).
  • Pregnant or breastfeeding women.
  • Positive for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV). Patients with positive Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) must have a negative Hepatitis B Virus (HBV) DNA test (quantitative detection < 500 IU/mL).
  • History of active tuberculosis.
  • Active autoimmune disease requiring systemic treatment within the past 2 years (except physiological replacement therapy for thyroid, insulin, or adrenal/pituitary insufficiency).
  • Serious uncontrolled concurrent medical conditions, including uncontrolled diabetes, interstitial lung disease, New York Heart Association (NYHA) Class III/IV heart failure, severe cardiac arrhythmias, or recent (within 6 months) myocardial infarction or cerebrovascular accidents.
  • Active Central Nervous System (CNS) or leptomeningeal metastases. Patients with treated brain metastases are eligible if they are stable (no progression via Magnetic Resonance Imaging (MRI)) for at least 8 weeks post-treatment and 28 days prior to the first dose, and do not require immunosuppressive doses of corticosteroids (>10 mg/day prednisone equivalent) for at least 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 procedures) within 4 weeks prior to treatment.
  • History of psychiatric disorders or persistent drug/substance abuse.
  • Other malignancies within the past 5 years, except for successfully treated localized cancers such as basal/squamous cell skin cancer or in situ carcinomas (cervix, breast, prostate).
  • Any other acute or chronic medical/psychiatric condition or laboratory abnormality that, in the investigator's opinion, increases research-related risk or interferes with the interpretation of study results.
  • Any condition that is not in the best interest of the participant.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xingchen Peng, Professor contact

+8618980606753

pxx2014@163.com

Yuting Yan, Doctor contact

yutingyan98@yeah.net

China2 sites, 2 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Xingchen Peng, +8618980606753, pxx2014@163.com

    Not yet recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Xingchen Peng, Ph.D, +8618980606753, pxx2014@163.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Tolerability of Au-TMP Nanoparticles in Combination With Radiotherapy for Patients With Advanced Melanoma Receiving 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.

Read the detailed description

Overcoming radioresistance and enhancing the clinical efficacy of immune checkpoint inhibitors remain significant challenges in the treatment of advanced melanoma. Au-TMP nanoparticles serve as an innovative radiosensitizing platform engineered based on the specific enzymatic characteristics of the melanoma microenvironment, enabling in situ aggregation and prolonged intratumoral retention to significantly amplify the local cytotoxic effects of radiation through physical energy deposition. This study employs a scientifically structured sequential administration protocol: an ultrasound- or Computed Tomography (CT)-guided intratumoral injection, fractionated radiotherapy (30 Gy in 5 fractions), and commencement of systemic anti-PD-1 therapy. This regimen is designed to facilitate the capture of tumor-associated antigens by Au-TMP and induce immunogenic cell death (ICD), thereby potentially reversing the immunosuppressive microenvironment. Ultimately, this research aims to evaluate the safety and tolerability of this combination approach while assessing preliminary clinical efficacy in patients with advanced melanoma.

Being tested
Au-TMP, Fractionated Radiotherapy (RT), Toripalimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Au-TMPDrug

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

  • Fractionated Radiotherapy (RT)Radiation

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

  • ToripalimabDrug

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

Study groups in NCT07562841
Study groupRoleWhat they receive
Au-TMP Plus Radiotherapy and ToripalimabExperimentalPatients receive a single intratumoral injection of Au-TMP followed by radiotherapy and systemic Toripalimab.
Receives: Drug: Au-TMP; Radiation: Fractionated Radiotherapy (RT); Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    DLT is defined as any toxicity event occurring within the DLT observation period (from the day of Au-TMP intratumoral injection to Day 28) that is judged by the investigator to be related (possibly, probably, or definitely related) to Au-TMP and meets the pre-specified DLT criteria defined in the protocol.

    Measured: From the administration of Au-TMP (Day 1) through Day 28.

Secondary outcomes (3)

  1. Incidence and Severity of Adverse Events (AEs)

    Incidence, severity, and causality of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs). All events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

    Measured: Up to 12 months from the date of Au-TMP administration.

  2. Pharmacokinetic (PK) Parameters

    Concentration-time curves and related PK parameters of gold (Au) elements in whole blood, plasma, and urine following intratumoral injection of Au-TMP.

    Measured: Day 1 (pre-injection, 1h, 2h, 4h, 8h, 24h post-injection), and Days 4, 8, 15, 28.

  3. Objective Response Rate (ORR)

    The proportion of participants who achieve a Complete Response (CR) or Partial Response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria [with immune-modified RECIST (iRECIST) criteria as a secondary reference].

    Measured: Baseline up to disease progression or up to 12 months from the date of Au-TMP administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start28 Apr 2026
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07562841
Sponsor's protocol ID
2026-811
Status last verified
Sep 2026
First submitted
24 Apr 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bonvalot S, Rutkowski PL, Thariat J, Carrere S, Ducassou A, Sunyach MP, Agoston P, Hong A, Mervoyer A, Rastrelli M, Moreno V, Li RK, Tiangco B, Herraez AC, Gronchi A, Mangel L, Sy-Ortin T, Hohenberger P, de Baere T, Le Cesne A, Helfre S, Saada-Bouzid E, Borkowska A, Anghel R, Co A, Gebhart M, Kantor G, Montero A, Loong HH, Verges R, Lapeire L, Dema S, Kacso G, Austen L, Moureau-Zabotto L, Servois V, Wardelmann E, Terrier P, Lazar AJ, Bovee JVMG, Le Pechoux C, Papai Z. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Aug;20(8):1148-1159. doi: 10.1016/S1470-2045(19)30326-2. Epub 2019 Jul 8.

    PubMed 31296491

  • Zhang Y, Huang F, Ren C, Liu J, Yang L, Chen S, Chang J, Yang C, Wang W, Zhang C, Liu Q, Liang XJ, Liu J. Enhanced Radiosensitization by Gold Nanoparticles with Acid-Triggered Aggregation in Cancer Radiotherapy. Adv Sci (Weinh). 2019 Jan 8;6(8):1801806. doi: 10.1002/advs.201801806. eCollection 2019 Apr 17.

    PubMed 31016110

  • Jiang Y, Cao H, Deng H, Guan L, Langthasa J, Colburg DRC, Melemenidis S, Cotton RM, Aleman J, Wang XJ, Graves EE, Kalbasi A, Pu K, Rao J, Le QT. Gold-siRNA supraclusters enhance the anti-tumor immune response of stereotactic ablative radiotherapy at primary and metastatic tumors. Nat Biotechnol. 2025 Sep;43(9):1496-1509. doi: 10.1038/s41587-024-02448-0. Epub 2024 Oct 24.

    PubMed 39448881

  • Gorodetska I, Schulz A, Behre G, Dubrovska A. Confronting Melanoma Radioresistance: Mechanisms and Therapeutic Strategies. Cancers (Basel). 2025 Aug 14;17(16):2648. doi: 10.3390/cancers17162648.

    PubMed 40867277

  • Zhao Y, Zhang T, Wang Y, Lu D, Du J, Feng X, Zhou H, Liu N, Zhu H, Qin S, Liu C, Gao X, Yang Z, Liu Z. ICAM-1 orchestrates the abscopal effect of tumor radiotherapy. Proc Natl Acad Sci U S A. 2021 Apr 6;118(14):e2010333118. doi: 10.1073/pnas.2010333118.

    PubMed 33785590

  • Sheng X, Huang G, Fang M, Li K, Wu D, Zhang X, Chen J, Zhu D, Chen Y, Li H, Gao Q, Wu L, Tang B, Yan X, Zeng R, Li J, Yu W, Xu J, Hao Y, Jin C, Zou J, Guo J. Toripalimab vs Dacarbazine as First-Line Therapy for Advanced Melanoma of Acral Subtype: The Phase 3 MELATORCH Randomized Clinical Trial. JAMA Oncol. 2026 Mar 1;12(3):243-250. doi: 10.1001/jamaoncol.2025.5751.

    PubMed 41481311

  • Jalil A, Donate MM, Mattei J. Exploring resistance to immune checkpoint inhibitors and targeted therapies in melanoma. Cancer Drug Resist. 2024 Oct 31;7:42. doi: 10.20517/cdr.2024.54. eCollection 2024.

    PubMed 39534873

  • Seth R, Agarwala SS, Messersmith H, Alluri KC, Ascierto PA, Atkins MB, Bollin K, Chacon M, Davis N, Faries MB, Funchain P, Gold JS, Guild S, Gyorki DE, Kaur V, Khushalani NI, Kirkwood JM, McQuade JL, Meyers MO, Provenzano A, Robert C, Santinami M, Sehdev A, Sondak VK, Spurrier G, Swami U, Truong TG, Tsai KK, van Akkooi A, Weber J. Systemic Therapy for Melanoma: ASCO Guideline Update. J Clin Oncol. 2023 Oct 20;41(30):4794-4820. doi: 10.1200/JCO.23.01136. Epub 2023 Aug 14.

    PubMed 37579248

  • Chinese guidelines for diagnosis and treatment of melanoma 2018 (English version). Chin J Cancer Res. 2019 Aug;31(4):578-585. doi: 10.21147/j.issn.1000-9604.2019.04.02. No abstract available.

    PubMed 31564801

  • Chi Z, Li S, Sheng X, Si L, Cui C, Han M, Guo J. Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases. BMC Cancer. 2011 Feb 25;11:85. doi: 10.1186/1471-2407-11-85.

    PubMed 21349197

  • Okobi OE, Abreo E, Sams NP, Chukwuebuni OH, Tweneboa Amoako LA, Wiredu B, Uboh EE, Ekechi VC, Okafor AA. Trends in Melanoma Incidence, Prevalence, Stage at Diagnosis, and Survival: An Analysis of the United States Cancer Statistics (USCS) Database. Cureus. 2024 Oct 2;16(10):e70697. doi: 10.7759/cureus.70697. eCollection 2024 Oct.

    PubMed 39493095

  • Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.

    PubMed 38230766

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Au-TMP, Fractionated Radiotherapy (RT) and Toripalimab in people with Advanced Melanoma, run by West China Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xingchen Peng, Professor (+8618980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicities (DLTs) (time frame: From the administration of Au-TMP (Day 1) through Day 28.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07562841, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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