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

Prior treatment

• 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.
• 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.
• Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
• Known alcohol or drug dependence.

Other illness

• Small cell lung cancer (SCLC) components in the histopathology.
• Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
• Serious cardiovascular or cerebrovascular diseases.
• Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.

Other

• Uncontrolled third-space effusion.
• Pregnant or breastfeeding women, or individuals planning to conceive. -

• 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.
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