Phase III Study of MHB009C 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 preliminary effectiveness of MHB009C monotherapy in patients with advanced solid tumors. This first-in-human Phase III clinical trial is open-label and multicenter, designed to find the best dose and assess initial tumor response in patients whose tumors are resistant or have no standard treatment options. The study has two parts a dose escalation phase and a dose expansion phase. During the dose escalation phase, patients receive increasing doses of MHB009C administered intravenously every three weeks to determine the maximum tolerated dose and monitor safety. After establishing a recommended dose, the dose expansion phase further evaluates this dose and others for safety and efficacy across different solid tumor types. Participants continue treatment until unacceptable side effects or disease progression occur. Participants will attend regular visits for assessments including tumor measurements using RECIST v1.1 criteria, safety monitoring for adverse events, and blood tests to study drug levels and immune response. The primary outcomes include dose-limiting toxicities and tumor response, with follow-up lasting up to five years. Researchers will also track overall survival, duration of response, and disease control. Safety events and antibody development against MHB009C will be closely monitored throughout and after treatment.

A Study of MHB009C in Patients With Advanced Solid Tumors