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

NCT07562841 | Not Yet Recruiting Phase 1

• 1 other identifier: 2026-811
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 Au-TMP, an innovative nanoparticle platform, in patients with advanced melanoma. This single-arm, open-label, Phase Ia 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

Advanced Melanoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Incidence and Severity of Adverse Events

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

• Pharmacokinetic (PK) Parameters

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

• Objective Response Rate (ORR)

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

Other Outcomes (2)

• Progression-Free Survival (PFS) and Overall Survival (OS)

  From the date of Au-TMP administration until the date of first documented progression or death from any cause (up to 2 years)

• Peripheral blood immune microenvironment changes

  Up to 3 months from the date of Au-TMP administration

Study Arms (1)

Au-TMP Plus Radiotherapy and Toripalimab

EXPERIMENTAL

Patients receive a single intratumoral injection of Au-TMP followed by radiotherapy and systemic Toripalimab.

Drug: Au-TMP; Radiation: Fractionated Radiotherapy (RT); Drug: Toripalimab

Interventions

Au-TMP DRUG

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

Au-TMP Plus Radiotherapy and Toripalimab

Fractionated Radiotherapy (RT) RADIATION

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

Au-TMP Plus Radiotherapy and Toripalimab

Toripalimab DRUG

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

Au-TMP Plus Radiotherapy and Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 90 × 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L. (No G-CSF, platelet transfusion, or erythropoietin/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); AST, ALT, and ALP ≤ 2.5 × ULN (≤ 5.0 × ULN for patients with documented liver or bone metastases); Serum albumin ≥ 2.8 g/dL.
• Coagulation: 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.

You may not qualify if:

• 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.
• 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 HIV or HCV. Patients with positive HBsAg or HBcAb must have a negative 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, 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 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (12)

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MeSH Terms

Interventions

chloro(triethylphosphine)gold(I); toripalimab

Central Study Contacts

Xingchen Peng, Professor

CONTACT

+8618980606753; pxx2014@163.com

Yuting Yan, Doctor

CONTACT

yutingyan98@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)