Actively Recruiting
A Study of MHB042C in Patients With Advanced Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-04-09
200
Participants Needed
1
Research Sites
200 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 MHB042C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB042C monotherapy.
CONDITIONS
Official Title
A Study of MHB042C in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent
- Age 18 years or older, any gender
- ECOG performance status of 0-1
- Estimated life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced solid tumors refractory, intolerant, or without standard treatment options
- At least one measurable lesion per RECIST v1.1 or one bone lesion
- Adequate bone marrow reserve and organ function
You will not qualify if you...
- History of two or more primary malignancies within 5 years before consent
- Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first dose
- Use of other unmarketed investigational drugs or therapies within 4 weeks before first dose
- Presence of brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression
- Severe bone damage from prostate cancer bone metastasis
- Unrecovered adverse reactions from prior anti-tumor treatment worse than CTCAE Grade 1
- Severe lung disease affecting lung function
- Vaccination within 4 weeks before dosing
- Active systemic infection requiring treatment within 7 days before dosing
- Serious cardiovascular or cerebrovascular diseases
- Uncontrolled third-space effusions
- 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 components
- Drug abuse or medical/psychiatric conditions interfering with participation or results
- Known alcohol or drug dependence
- Pregnant, breastfeeding, or 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
C
CMO/ Senior Vice President 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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