A Study of MHB048C in Patients With Advanced Solid Tumors

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 the first dose of investigational drug.
• Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
• Vaccinated within 4 weeks before dosing.
• Active systemic infection requiring treatment within 7 days before dosing.
• Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
• Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
• Known alcohol or drug dependence.

Other illness

• Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
• Severe bone damage caused by bone metastasis of prostate cancer.
• Severe lung disease affecting pulmonary function.
• Serious cardiovascular or cerebrovascular diseases.
• Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.

Other

• Uncontrolled third-space effusions not suitable for enrollment.
• 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, no restriction on gender.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated life expectancy ≥ 3 months.
• Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
• At least one measurable lesion per RECIST v1.1 criteria or one bone.
• Adequate bone marrow reserve and organ function. -