A Phase 1 Study to Find the Safe Dose and Effects of ZG006 Given by IV in Adults with Small Cell Lung Cancer Who Have Not Responded to Standard Treatments

What this Trial Is About

Researchers are conducting a multi-center, open-label Phase 1 clinical trial to study ZG006 in people with small cell lung cancer who have not responded to or cannot tolerate existing standard treatments. The study aims to find the maximum tolerated dose and recommended dose for further research, focusing on safety, tolerability, and how the drug behaves in the body. This early phase trial uses a dose escalation design to carefully evaluate dosing levels. ZG006 is given to participants as an intravenous infusion. The trial follows a standard 33 dose escalation approach during which different doses are tested to determine the best dose for future studies. This phase includes monitoring for dose-limiting toxicities and adverse events to assess safety. The study is expected to last about two years for evaluating dosing and safety outcomes. Participants will be monitored closely with various assessments including laboratory tests to detect side effects and the presence of anti-drug antibodies. Researchers will measure how the drug is processed in the body, its concentration over time, and its effects on tumor response. The study includes regular safety checks and follows participants for up to two years to gather comprehensive data on treatment effects and tolerability.

A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer