A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer
brief summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB036C combined with MHB039A or other anti-tumor therapy in patients with advanced lung cancer. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB036C combined with MHB039A or other anti-tumor therapies.
detailed description
This first-in-human clinical trial of MHB036C combined with MHB039A or other anti-tumor therapy comprises two parts: a dose escalation phase and dose expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB036C combining different anti-tumor treatment regimens (including Furmonertinib, MHB039A for injection, and Carboplatin) in patients with advanced lung cancer, and to determine the maximum tolerated dose (MTD). Additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.
Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the dose expansion phase to further evaluate the safety and efficacy of MHB036C combined with MHB039A or other anti-tumor therapy in patients with specific types of advanced lung cancer.
official title
A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer