Phase III Study of MHB042C to Assess Safety, Tolerability, and Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating MHB042C, a new drug, in patients with advanced solid tumors in this first-in-human Phase III study. The study aims to assess the safety, tolerability, how the drug is processed in the body pharmacokinetics, and early signs of effectiveness of MHB042C given alone. It includes patients whose tumors are resistant to or have no standard treatment options. The study has two parts a dose escalation phase and a dose expansion phase. In the dose escalation phase, participants receive increasing doses of MHB042C given intravenously every two or three weeks to find the maximum tolerated dose. After determining safe doses and collecting initial data, the dose expansion phase will further evaluate safety and effectiveness in specific tumor types. Participants continue treatment until unacceptable side effects or disease progression occur. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST criteria, safety monitoring for side effects, and blood tests to study drug levels and immune response. The primary outcomes include identifying dose-limiting toxicities and tumor response rates. Secondary outcomes evaluate duration of response, overall survival, and other safety and pharmacokinetic parameters. Participants may be followed for up to five years to monitor long-term outcomes and safety.

A Study of MHB042C in Patients With Advanced Solid Tumors