NCT07229599

A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer

A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, open-label, multicenter Phase I/II study of MHB036C combined with MHB039A or other anti-tumor therapy in patients with advanced lung cancer. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB036C combined with MHB039A or other anti-tumor therapies.

Detailed description

This first-in-human clinical trial of MHB036C combined with MHB039A or other anti-tumor therapy comprises two parts: a dose escalation phase and dose expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB036C combining different anti-tumor treatment regimens (including Furmonertinib, MHB039A for injection, and Carboplatin) in patients with advanced lung cancer, and to determine the maximum tolerated dose (MTD). Additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation. Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the dose expansion phase to further evaluate the safety and efficacy of MHB036C combined with MHB039A or other anti-tumor therapy in patients with specific types of advanced lung cancer.

Conditions

• Advanced Lung Cancer

Interventions

Type	Name	Description
DRUG	MHB036C for Injection	IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
DRUG	MHB039A for Injection	IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
DRUG	Furmonertinib	Oral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
DRUG	Carboplatin	IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Timeline

• Start date: 2025-05-09
• Primary completion: 2029-05-01
• Completion: 2030-05-01
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: China