Actively Recruiting
A Phase I/II Study Evaluating Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB009C Injection in Advanced Solid Tumor Patients
Led by Minghui Pharmaceutical (Hangzhou) Ltd ยท Updated on 2026-04-13
200
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of MHB009C monotherapy in patients with advanced solid tumors. This first-in-human Phase I/II clinical trial is open-label and multicenter, designed to find the best dose and assess initial tumor response in patients whose tumors are resistant or have no standard treatment options. The study has two parts: a dose escalation phase and a dose expansion phase. During the dose escalation phase, patients receive increasing doses of MHB009C administered intravenously every three weeks to determine the maximum tolerated dose and monitor safety. After establishing a recommended dose, the dose expansion phase further evaluates this dose and others for safety and efficacy across different solid tumor types. Participants continue treatment until unacceptable side effects or disease progression occur. Participants will attend regular visits for assessments including tumor measurements using RECIST v1.1 criteria, safety monitoring for adverse events, and blood tests to study drug levels and immune response. The primary outcomes include dose-limiting toxicities and tumor response, with follow-up lasting up to five years. Researchers will also track overall survival, duration of response, and disease control. Safety events and antibody development against MHB009C will be closely monitored throughout and after treatment.
CONDITIONS
Brief Title
A Study of MHB009C 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
- Histologically or cytologically confirmed advanced solid tumors refractory or intolerant to standard therapy or with no standard treatment options
- At least one measurable lesion according to RECIST v1.1 criteria or 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 prior to consent
- Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose
- Use of other 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
- Unresolved adverse reactions from previous anti-tumor treatments worse than CTCAE 5.0 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 dosing
- Known hypersensitivity or delayed allergic reactions to the investigational product or its components
- Drug abuse or medical/psychiatric conditions interfering with participation
- Known alcohol or drug dependence
- Pregnant or breastfeeding women, or 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 - Until the end of the study in the absence of unacceptable toxicities and confirmed disease progression
Participants receive intravenous MHB009C every 3 weeks. Treatment continues until the end of the study unless unacceptable toxicities or confirmed disease progression occur.
Repeated visits every 3 weeks for drug administration
Duration - Up to approximately 5 years
Participants are monitored for safety, efficacy, and survival outcomes up to approximately 5 years after starting treatment.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center, Shanghai
Shanghai, Shanghai Municipality, China, 201419
Actively Recruiting
Research Team
C
CMO/ Senior Vice President 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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here