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Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma
This is primarily a safety study that is designed to evaluate IFx-Hu2.0 monotherapy and provide foundational evidence to potentially support further studies investigating IFx-Hu2.0 + anti-PD-1 combination therapy for patients with advanced MCC or cSCC.
Primary Objective The primary objective is to assess the safety of vaccinating patients with advanced MCC or cSCC with intralesional IFx-Hu2.0. Secondary Objective Secondary objectives are to assess the feasibility of IFx-Hu2.0 administration and evaluate any preliminary efficacy in patients with advanced MCC or cSCC.