Phase III Study of MHB088C and MHB039A Combination Therapy in Adults With Advanced Malignant Solid Tumors

What this Trial Is About

Researchers are evaluating MHB088C combined with MHB039A in patients with advanced malignant solid tumors. This first-in-human, open-label Phase III study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of this combination therapy. The study includes patients with advanced solid tumors that have limited treatment options or are refractory to standard therapies. The study has two parts a dose escalation phase and an indication expansion phase. During the dose escalation phase, patients receive MHB088C and MHB039A intravenously every two weeks to determine the maximum tolerated dose and assess safety. Based on these results, the indication expansion phase will further evaluate safety and efficacy in patients with specific advanced solid tumors. The treatment involves multiple cohorts, all receiving the combination therapy by intravenous infusion every two weeks. Participants will undergo regular evaluations, including tumor response assessments based on RECIST v1.1 criteria, safety monitoring for adverse events, and pharmacokinetic sampling to measure drug levels. These assessments continue until disease progression, death, loss to follow-up, or withdrawal, with follow-up lasting up to approximately five years. The study also tracks overall survival, disease control rate, and progression-free survival. Safety and tolerability are closely monitored throughout the study period.

A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors