Actively Recruiting
An Open-label Phase I/II Clinical Study of MHB088C for Injection Combined With MHB039A for Injection in Patients With Advanced Malignant Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd ยท Updated on 2025-11-18
116
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MHB088C combined with MHB039A in patients with advanced malignant solid tumors. This first-in-human, open-label Phase I/II study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of this combination therapy. The study includes patients with advanced solid tumors that have limited treatment options or are refractory to standard therapies. The study has two parts: a dose escalation phase and an indication expansion phase. During the dose escalation phase, patients receive MHB088C and MHB039A intravenously every two weeks to determine the maximum tolerated dose and assess safety. Based on these results, the indication expansion phase will further evaluate safety and efficacy in patients with specific advanced solid tumors. The treatment involves multiple cohorts, all receiving the combination therapy by intravenous infusion every two weeks. Participants will undergo regular evaluations, including tumor response assessments based on RECIST v1.1 criteria, safety monitoring for adverse events, and pharmacokinetic sampling to measure drug levels. These assessments continue until disease progression, death, loss to follow-up, or withdrawal, with follow-up lasting up to approximately five years. The study also tracks overall survival, disease control rate, and progression-free survival. Safety and tolerability are closely monitored throughout the study period.
CONDITIONS
Brief 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 in the study and signs the informed consent form.
- Age 18 years or older, with no gender restriction.
- 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, intolerant, or with no standard therapy 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.
- Adequate bone marrow reserve and organ function.
- Participants of childbearing potential must agree to reliable contraceptive measures during the study and for at least 12 weeks after last dose.
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, or biologic/endocrine/immunotherapy within 4 weeks before dosing.
- Use of other investigational drugs or therapies within 4 weeks before dosing.
- Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
- Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before first dose or requiring surgery during study.
- Previous or ongoing gastrointestinal perforation, surgical wound 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 impairing pulmonary function.
- Active systemic infection requiring treatment within 7 days before dosing.
- Uncontrolled third-space effusion.
- Serious cardiovascular or cerebrovascular diseases.
- Known hypersensitivity or delayed allergic reaction to the investigational products.
- Drug abuse or other medical/psychiatric conditions interfering with participation.
- Alcohol or drug dependence.
- Pregnant or breastfeeding women, or planning to conceive.
AI-Screening
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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 day 28 from the first dose for Q2W administration during dose escalation; continued during indication expansion phase until disease progression or discontinuation.
Participants receive MHB088C and MHB039A combination therapy by intravenous administration every 2 weeks.
Visits every 2 weeks for dosing and assessments
Duration - Up to approximately 5 years
Participants are monitored for safety, tumor response, and survival for up to approximately 5 years after treatment.
Regular follow-up visits during monitoring period
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
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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