Clinical trial for Advanced Melanoma
Official title Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy
ClinicalTrials.gov ID: NCT07562841
What this study is testing
What is Au-TMP?
an investigational intratumoral injection being studied as a potential treatment for advanced melanoma is designed to aggregate in the melanoma microenvironment and act as a radiosensitizing gold nanoparticle platform to enhance radiation damage
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the gold nanoparticle injection is safe and tolerable when used with radiation and the anti‑PD‑1 drug Toripalimab.
- Who it's for
- Adults with advanced melanoma who have not responded well to standard treatments.
- What's involved
- Participants receive one injection of the gold nanoparticle directly into the tumor, then get radiation therapy and the anti‑PD‑1 drug Toripalimab.
- Time commitment
- The trial lasts about a few weeks to months, with several clinic visits for injections, radiation sessions, and drug administration.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
- 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...
You likely can't join 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...
- Ocular (uveal) or mucosal melanoma.
See the full eligibility criteria
- 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.
- 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...
- 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.
- 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.
- 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
- 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)...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chengdu, Sichuan, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.