Actively Recruiting
A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2025-11-17
300
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent
- Age 18 to 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Estimated life expectancy of at least 3 months
- For dose escalation: confirmed advanced solid tumors resistant or intolerant to standard therapy or with no standard options
- For dose expansion: confirmed locally advanced or metastatic solid tumors not suitable for surgery or radical radiotherapy/chemotherapy
- At least one measurable lesion per RECIST v1.1
- Adequate bone marrow and organ function
- Participants of childbearing potential must agree to use reliable contraception during the study and for 12 weeks after last dose
You will not qualify if you...
- Small cell lung cancer components in pathology
- History of 2 or more primary cancers within 5 years before consent
- Chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic/endocrine/immunotherapy within 4 weeks before first dose
- Use of other unapproved investigational drugs within 4 weeks before dosing
- Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression
- Major organ surgery or significant trauma within 4 weeks before first dose or planned surgery during study
- Previous or current gastrointestinal perforation or wound healing complications, bleeding events
- Intravenous thrombolysis within 2 weeks except preventive anticoagulation/antiplatelet therapy
- Vaccination within 4 weeks before dosing
- Systemic corticosteroid treatment within 14 days before dosing
- Severe lung impairment, interstitial lung disease, pneumonia requiring steroids, or previous pneumonectomy
- Active systemic infection requiring treatment within 7 days before dosing
- Uncontrolled third-space fluid accumulation
- Serious heart or brain blood vessel diseases
- Known allergy to study drug or components
- Drug abuse or medical/psychiatric conditions interfering with participation
- Known alcohol or drug dependence
- Pregnant or breastfeeding women or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
CMO/ Senior Vice President of R&D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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