Phase I Study of SH009 Injection Treatment for Adults With Advanced Solid Tumors Evaluating Safety, Effectiveness, and Drug Behavior

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and behavior in the body of SH009 injection therapy in patients with advanced solid tumors. This Phase I clinical study focuses on various tumor types including gastric, liver, head and neck, breast, non-small cell lung, and esophageal cancers. The aim is to select safe and effective tumor types and doses for further studies and to help determine the recommended dose for future trials. Participants will receive SH009 at a dose of 40 mgkg once weekly, with treatment cycles lasting 28 days. The study includes dose expansion to assess safety, efficacy, and pharmacokinetics. It is an open, multicenter trial with no placebo or masking, focusing on patients whose cancer has progressed or who cannot tolerate standard treatments. During the study, participants will undergo regular assessments including measuring tumor response, survival rates, and monitoring side effects for up to two years. Researchers will collect tumor tissue samples for biomarker analysis and monitor blood levels of the drug and immune responses. Safety will be closely followed from consent through 90 days after the last dose, with long-term follow-up of treatment effects and survival outcomes.

A Study of SH009 Injection in Patients With Advanced Solid Tumors.