Au-TMP and Radiotherapy for Advanced Melanoma With 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

Trial Details

NCT ID
NCT07562841
Phase
PHASE1
Sponsor
West China Hospital
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Au-TMP
  • Fractionated Radiotherapy (RT)
  • Toripalimab
Locations (sample)
  • Chengdu, Sichuan, China|30.66667,104.06667
  • Chengdu, Sichuan, China|30.66667,104.06667

Key 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. Prior adjuvant or neoadjuvant therapy is permi…
  • Presence of at least one measurable lesion according to RECIST v1.1 criteria.

For full eligibility, visit ClinicalTrials.gov.

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