Phase III Study of SHR-3276 Injection to Assess Safety and Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of SHR-3276 for injection in patients with advanced solid tumors that have not responded to standard treatments. This open-label, multicenter clinical trial is being conducted as a Phase III study to better understand how SHR-3276 works in this patient population. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. and aims to gather detailed safety and efficacy data over several years. SHR-3276 is given through intravenous infusion at preset dose levels in a dose escalation stage. Following this, selected dose cohorts will enter a dose expansion phase to further evaluate the treatment. The study also includes an indication expansion period to assess preliminary efficacy in different tumor types. Patients will receive SHR-3276 according to the assigned dose level throughout the study. Participants will be monitored closely for adverse events for up to three years, with assessments including the maximum tolerated dose, recommended dose, and pharmacokinetic measurements like maximum concentration and time to maximum concentration. Researchers will also evaluate response rates, duration of response, disease control, progression-free survival, and overall survival. Safety will be tracked carefully, and participants are expected to be followed for at least three years to collect comprehensive data on treatment effects and tolerability.

A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors