Actively Recruiting
A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2025-11-18
116
Participants Needed
1
Research Sites
306 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 MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.
CONDITIONS
Official Title
A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs the informed consent form
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- For dose escalation: Histologically or cytologically confirmed advanced solid tumors refractory or intolerant to standard therapy or without standard options
- For dose expansion: Histologically or cytologically confirmed locally advanced or metastatic solid tumors not suitable for radical surgery or radiotherapy/chemotherapy
- At least one measurable lesion per RECIST v1.1 criteria
- Adequate bone marrow and organ function
- Participants of childbearing potential must agree to reliable contraceptive measures during the study and for 12 weeks after last dose
You will not qualify if you...
- History of two or more primary malignancies within 5 years prior to consent
- Chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic/endocrine/immunotherapy within 4 weeks before dosing
- Use of unmarketed investigational drugs within 4 weeks before dosing
- Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression
- Major organ surgery (except biopsy) or significant trauma within 4 weeks before first dose or requiring elective surgery during study
- Previous or ongoing gastrointestinal perforation, wound healing complications, or bleeding events
- Intravenous thrombolysis within 2 weeks, except preventive anticoagulation/antiplatelet therapy
- Vaccination within 4 weeks before dosing
- Systemic corticosteroid treatment within 14 days before dosing
- Severe lung disease affecting pulmonary function
- Active systemic infection requiring treatment within 7 days before dosing
- Uncontrolled third-space effusion
- Serious cardiovascular or cerebrovascular diseases
- Known allergy or delayed reaction to investigational products
- Drug abuse or medical/psychiatric conditions interfering with study
- 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
Ethics Committee of Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 201419
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
4
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