Actively Recruiting
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
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2025-11-17
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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 I/II 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
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 0-1.
- Estimated life expectancy of at least 3 months.
- Histologically or cytologically confirmed advanced solid tumors refractory to or intolerant of standard therapy (dose escalation stage).
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors not suitable for radical surgery or radiotherapy/chemotherapy (dose expansion stage).
- At least one measurable lesion according to RECIST v1.1.
- Adequate bone marrow and organ function.
- Participants of childbearing potential agree to use reliable contraception during the study and for at least 12 weeks after last dose.
You will not qualify if you...
- Presence of small cell lung cancer components.
- History of two or more primary malignancies 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 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 need for elective surgery during study.
- Previous or current gastrointestinal perforation or wound healing complications.
- Intravenous thrombolysis within 2 weeks except preventive anticoagulation.
- Vaccination within 4 weeks before dosing.
- Systemic corticosteroids within 14 days before dosing.
- Severe lung function impairment, interstitial lung disease, pneumonia requiring steroids, or prior pneumonectomy.
- Active systemic infection requiring treatment within 7 days before dosing.
- Uncontrolled third-space fluid buildup.
- Serious cardiovascular or cerebrovascular diseases.
- Known allergies to study drugs or components.
- Drug abuse, psychiatric conditions interfering with participation.
- Known alcohol or drug dependence.
- Pregnant or breastfeeding, or planning pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression, unacceptable toxicity, or withdrawal
Participants receive MHB036C combined with other anti-tumor therapies including Furmonertinib, MHB039A, or Carboplatin. Treatment continues until unacceptable toxicities or disease progression occur.
Repeated visits every 3 weeks for intravenous administration and daily oral medication as applicable
Duration - Up to 5 years
Participants are monitored for safety and tumor response after treatment ends, up to approximately 5 years.
Periodic visits as per investigator schedule
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
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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