Phase I Study of MHB118C Injection to Assess Safety and Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating MHB118C injection in adults with advanced malignant solid tumors that are resistant to or have no standard treatment options. This first-in-human, open-label Phase I study aims to assess the safety, tolerability, pharmacokinetics, and initial effectiveness of MHB118C given alone. The trial includes patients with tumors that can be measured by standard criteria and who have a good performance status and life expectancy of at least three months. The study has two parts a dose escalation phase where participants receive increasing doses of MHB118C every three weeks through intravenous infusion to find the maximum tolerated dose, followed by an indication expansion phase to further evaluate safety and effectiveness in specific tumor types. Patients will continue treatment until unacceptable side effects or confirmed disease progression occur. Additional patients may be enrolled in pharmacokinetic expansion cohorts after dose-limiting toxicity evaluations. Participants will undergo regular assessments including safety monitoring, pharmacokinetic blood tests, and tumor response evaluations according to RECIST criteria. Researchers will measure dose-limiting toxicities, adverse events, antibody levels, immune response, tumor response rates, disease control, progression-free survival, and overall survival over up to five years. The study involves ongoing follow-up until progression, withdrawal, or death, ensuring comprehensive long-term monitoring.

A Study of MHB118C Injection in Patients With Advanced Solid Tumors