Actively Recruiting
Phase III Study of MHB036C with MHB039A or Other Anti-tumor Drugs in Adults with Advanced Lung Cancer
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2025-11-17
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of MHB036C combined with MHB039A or other anti-tumor therapies in patients with advanced lung cancer. This first-in-human, open-label Phase III study aims to determine the maximum tolerated dose of MHB036C in combination with different anti-tumor regimens and further assess safety and efficacy in specific lung cancer types. The study includes two parts a dose escalation phase and a dose expansion phase. During dose escalation, patients receive MHB036C every three weeks intravenously combined with Furmonertinib orally daily, MHB039A intravenously every three weeks, or Carboplatin intravenously at a specified dose. Dose expansion will continue based on results from escalation to further evaluate these combinations. Participants receive treatment until unacceptable side effects or disease progression occur. Participants will undergo regular safety assessments, pharmacokinetic sampling, and tumor evaluations according to RECIST v1.1 criteria. Researchers will monitor adverse events up to about five years and measure outcomes such as maximum tolerated dose, tumor response, duration of response, disease control, and progression-free survival. The total participation time varies depending on individual treatment response and follow-up requirements.
CONDITIONS
Brief Title
A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer
Research Team
C
CMO/ Senior Vice President of R&D
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