Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy
ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Au-TMP
- Fractionated Radiotherapy (RT)
- Toripalimab
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov