Exploratory Study of LM103 Injection with PD-1 Therapy for Advanced Solid Tumors to Assess Safety and Early Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, immune response, and early effectiveness of LM103 injection combined with PD-1 therapy in patients with advanced solid tumors. This early phase 1 study focuses on patients with advanced melanoma, cervical or ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer, and other solid tumors that have not responded to or cannot tolerate standard treatments. Participants receive a combination of LM103 injection, PD-1 therapy, IL-2 therapy, fludarabine, and cyclophosphamide. Treatment is designed to assess how well patients tolerate the regimen and how their immune system responds. The therapies are administered under medical supervision, with LM103 manufacturing requiring tumor tissue collected by surgery or biopsy. During the study, participants undergo regular monitoring for adverse events including immune-related side effects, as well as assessments of tumor response using standard criteria. Researchers track outcomes such as objective response rate, disease control rate, time to response, progression-free survival, and overall survival over about one year. Participants are followed closely to evaluate safety and treatment effects throughout the study period.

An Exploratory Clinical Study to Evaluate the Safety, Tolerability, Immune Response and Preliminary Efficacy of LM103 Injection in Combination With PD-1 in Patients With Advanced Solid Tumours