Phase IbIIa Study of T3011 Injection for Treating Advanced Melanoma Evaluating Safety, Tolerability, and Early Effectiveness

What this Trial Is About

Researchers are evaluating the tolerability, safety, and early effectiveness of T3011 in adults with advanced melanoma. This clinical study is designed as a phase IbIIa trial to understand how participants with measurable melanoma lesions respond to this treatment. The study is led by Shanghai Pharmaceuticals Holding Co., Ltd and focuses on treatment outcomes over approximately two years. Participants receive T3011 delivered directly into the tumor every two weeks. This treatment period is followed by ongoing monitoring to assess responses and any side effects. The trial includes a single group of participants all receiving T3011, without a comparison placebo or alternative treatment group. Throughout the study, participants undergo various assessments including laboratory tests and evaluations of tumor response. Researchers measure treatment-emergent adverse events and objective response rate as primary outcomes, along with disease control rate, remission duration, progression-free survival, and overall survival as secondary outcomes. The total study duration is approximately two years, during which safety and efficacy are closely monitored.

A Clinical Study of T3011 in Subjects With Advanced Melanoma