A Study of MHB048C in Patients With Advanced Solid Tumors
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors
Minghui Pharmaceutical (Hangzhou) Ltd
200 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
Summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.
Eligibility
Inclusion Criteria7
- 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. -
Exclusion Criteria16
- 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.
- Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
- Severe bone damage caused by bone metastasis of prostate cancer.
- Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
- Severe lung disease affecting pulmonary function.
- Vaccinated within 4 weeks before dosing.
- Active systemic infection requiring treatment within 7 days before dosing.
- Serious cardiovascular or cerebrovascular diseases.
- Uncontrolled third-space effusions not suitable for enrollment.
- 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.
- 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. -
Interventions
IV administration of MHB048C Q2W or Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07192120