Phase III Open-label Multicenter Study to Assess Safety and Effectiveness of HB0036 in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating HB0036, a drug being studied for patients with advanced solid tumors, including non-small cell lung cancer NSCLC. This Phase III, open-label, multicenter trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and effectiveness of HB0036. The study includes patients with locally advanced, recurrent, or metastatic solid tumors who have not responded to standard treatments. A Safety Review Committee will monitor safety data throughout the trial. Participants receive HB0036 through intravenous infusion every three weeks. The study is divided into two phases Phase I focuses on safety and tolerability, while Phase II evaluates safety and efficacy at the recommended Phase II dose in specific tumor groups, including NSCLC and other solid tumors. The study may adjust dosing schedules or include additional tumor types based on safety findings. During the study, participants undergo evaluations including tumor assessments by CT or MRI scans, blood tests to monitor organ function, and performance status checks. Researchers will measure safety and tolerability for up to 12 months and determine the maximum tolerated dose for up to 24 months. Pharmacokinetic parameters such as drug exposure and concentration will also be monitored. Total participation duration varies by patient condition and response.

A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors