A Single-arm, Multi-center Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety, and Initial Efficacy of T3011 Herpesvirus Injection Combined With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors

What this Trial Is About

Researchers are studying the safety and effectiveness of T3011, a herpesvirus injection, combined with PD-1/PD-L1 inhibitors in adults with advanced solid tumors. This clinical trial aims to evaluate how well this combination treatment works and how well patients tolerate it, with the study sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. It is a Phase Ib/IIa trial conducted at multiple centers. Participants will receive T3011 injected directly into tumors every two weeks, along with PD-1/PD-L1 inhibitors given by intravenous infusion at a dose of 3 mg/kg also every two weeks. Different dose levels of T3011 (high, middle, and low) are being tested to assess safety and initial effectiveness. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatments being given. During the study, participants will be closely monitored for side effects and treatment responses over about two years. Researchers will measure outcomes such as the rate of treatment-related adverse events, objective response rate, disease control rate, duration of remission, progression-free survival, and overall survival. Participants will undergo regular assessments including physical exams, laboratory tests, and imaging to track their progress and safety throughout the trial.

A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors