Actively Recruiting
A Study of MHB046C Injection in Patients With Advanced Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2025-09-18
200
Participants Needed
1
Research Sites
302 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 MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy.
CONDITIONS
Official Title
A Study of MHB046C Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate in the study and signs the informed consent form.
- Age 65 18 years, no restriction on gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy 65 3 months.
- Able to understand and comply with the study protocol and follow-up procedures.
- 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.
- Adequate organ function.
You will not qualify if you...
- History of 652 primary malignancies within 5 years prior to informed consent.
- Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
- Brain metastases (unless asymptomatic, no edema, stable 654 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.
- Severe lung disease affecting pulmonary function.
- Active systemic infection requiring treatment within 7 days before dosing.
- Serious cardiovascular or cerebrovascular diseases.
- Uncontrolled third-space effusions not suitable for enrollment.
- Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
V
VP 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
2
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