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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Lung Cancer

In brief

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.

Key facts

Study ID

NCT07229599

Run by

Minghui Pharmaceutical (Hangzhou) Ltd

People needed

300

Starts

2025-05-09

Expected to finish

2030-05-01

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily agrees to participate in the study and signs the informed consent form.
• Age ≥ 18 years and≤75 years, no restriction on gender.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated life expectancy ≥ 3 months.
• For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
• For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and/or radical concurrent/sequential radiotherapy and chemotherapy.
• At least one measurable lesion per RECIST v1.1 criteria.
• Adequate bone marrow reserve and organ function.
• Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.

You may not qualify if…

• Small cell lung cancer (SCLC) components in the histopathology.
• History of ≥2 primary malignancies within 5 years prior to informed consent.
• Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
• Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
• Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
• Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.
• Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.
• Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.
• Vaccinated within 4 weeks before dosing.
• Treated with systemic corticosteroids within 14 days before dosing.
• Severe impairment of pulmonary function; interstitial lung disease or a history of pneumonia requiring steroid treatment; previous left or right pneumonectomy.
• Active systemic infection requiring treatment within 7 days before dosing.
• Uncontrolled third-space effusion.
• Serious cardiovascular or cerebrovascular diseases.
• Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
• Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
• Known alcohol or drug dependence.
• Pregnant or breastfeeding women, or individuals planning to conceive. -

Where it is running

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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