Actively Recruiting
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MHB046C, a new drug, in patients with advanced solid tumors in a first-in-human Phase I/II clinical trial. The study aims to assess the safety, tolerability, how the drug moves through the body, and early signs of antitumor activity. It includes patients with advanced solid cancers who have limited or no standard treatment options. The trial consists of two parts: a dose escalation phase and an indication expansion phase. In the dose escalation phase, participants receive increasing doses of MHB046C through intravenous injections every three weeks to determine the maximum tolerated dose and study pharmacokinetics. Following this, the recommended dose and other potential doses will be further explored in the indication expansion phase, which involves multiple groups of patients with specific advanced solid tumors. Treatment continues until unacceptable side effects or disease progression. Participants will undergo evaluations for safety, response to treatment, and how the drug behaves in the body. Assessments include measuring tumor response using RECIST v1.1 criteria, monitoring adverse events, and pharmacokinetic and immunogenicity testing over up to five years. The study tracks outcomes such as overall response rate, duration of response, disease control rate, progression-free survival, and overall survival. Participants are monitored regularly for safety and efficacy throughout the study period.
CONDITIONS
Brief 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 and signs informed consent.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy of at least 3 months.
- Able to understand and comply with study procedures.
- Histologically or cytologically confirmed advanced solid tumors refractory to or intolerant of standard therapy, or no standard options.
- At least one measurable tumor lesion per RECIST v1.1.
- Adequate organ function.
You will not qualify if you...
- History of two or more primary malignancies within 5 years before consent.
- Chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first dose.
- Brain metastases unless asymptomatic, stable for at least 4 weeks without steroids, and no edema.
- Leptomeningeal disease, brainstem metastases, or spinal cord compression.
- Severe lung disease impairing lung function.
- Active systemic infection requiring treatment within 7 days before dosing.
- Serious cardiovascular or cerebrovascular disease.
- Uncontrolled third-space effusions.
- 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 to the study drug or its components.
- Drug abuse or psychiatric condition interfering with participation.
- Known alcohol or drug dependence.
- Pregnant or breastfeeding women or those planning to conceive.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 5 years or until discontinuation
Participants receive MHB046C by intravenous injection every 3 weeks. Treatment continues until unacceptable toxicities or disease progression occur.
Repeated visits every 3 weeks for treatment administration
Duration - Up to approximately 5 years after treatment
Participants are monitored for safety, efficacy, and survival after treatment ends, up to approximately 5 years.
Visits as needed for follow-up assessments
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
V
VP of R&D
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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