Phase III Study of MHB048C Injection to Assess Safety, Tolerability, and Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating MHB048C in this first-in-human, open-label, multicenter Phase III clinical trial for patients with advanced solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics how the drug moves through the body, and early signs of effectiveness of MHB048C when given alone. It also seeks to find the maximum tolerated dose and explore effects in specific tumor types including metastatic castration-resistant prostate cancer mCRPC. The trial has two parts a dose escalation phase and a dose expansion phase. During the dose escalation phase, patients receive increasing doses of MHB048C to determine safety and the best dose. There are seven escalating dose groups, with some patients enrolled to study pharmacokinetics and dose-limiting toxicities. The dose expansion phase follows, focusing on further evaluating safety and effectiveness of the recommended dose and other doses in patients with mCRPC or other advanced tumors. MHB048C is given by intravenous infusion every two or three weeks, and treatment continues until unacceptable side effects or disease progression occur. Participants will be closely monitored through regular assessments including tumor scans following RECIST criteria to measure response, safety checks for adverse events, and blood tests to study drug levels and immune reactions. The study tracks outcomes such as tumor response, disease control, progression-free survival, overall survival, and side effect severity for up to about five years. Pharmacokinetic data and immunogenicity will be collected early after dosing. Participants may remain in the study for several years with ongoing evaluations, ensuring thorough observation of treatment effects and safety over time.

A Study of MHB048C in Patients With Advanced Solid Tumors