RecruitingPhase 1Phase 2NCT07229599

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

Sponsor

Minghui Pharmaceutical (Hangzhou) Ltd

Enrollment

300 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Lung Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new drug called MHB036C, combined with other cancer treatments, for people with advanced lung cancer. The goal is to find safe doses and see how well it works. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced lung cancer (non-small cell type) confirmed by a biopsy or lab test - You are in generally good health and able to perform daily activities (ECOG score 0-1) - Your doctors estimate you have at least 3 months to live - Standard treatments have stopped working or you cannot tolerate them **You may NOT be eligible if...** - You are under 18 or over 75 years old - Your cancer has not been confirmed by biopsy or lab test - You have serious heart, liver, kidney, or blood problems - You are pregnant or breastfeeding - You have uncontrolled infections or other serious illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMHB036C for Injection

IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

DRUGMHB039A for Injection

IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

DRUGFurmonertinib

Oral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

DRUGCarboplatin

IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.