Study of SHR-4375 Injection in Patients with Advanced Solid Tumors An Open-label, Single-arm, Multicenter Phase I/II Trial Evaluating Safety, Tolerability, Pharmacokinetics, and Efficacy

What this Trial Is About

Researchers are conducting an open-label, single-arm, multicenter Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of SHR-4375 injection in patients with advanced solid tumors. This study focuses on patients who have measurable disease, have failed or cannot tolerate standard treatments, or have no available standard therapies. The goal is to better understand how SHR-4375 affects this patient population and to determine appropriate dosing. Participants will receive SHR-4375 injection as the investigational treatment throughout the study. The trial is divided into three parts, with no placebo or comparator group mentioned. The study will assess the dose limiting toxicity, maximal tolerable dose, and recommend a phase 2 dose over a monitoring period extending up to 12 months after the initial dose. During the study, participants will be closely monitored for adverse events from the first day of treatment until 90 days after the last dose. Researchers will evaluate safety through ongoing assessments, including pharmacokinetic measurements and tolerability. The study includes patients aged 18 years and older with an expected life expectancy of at least 12 weeks. Total participant involvement will depend on individual dosing schedules and response to treatment.

A Study of SHR-4375 in Subjects With Solid Tumors