Actively Recruiting
A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2025-11-18
210
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.
CONDITIONS
Official Title
A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other 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
- Aged 18 to 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- At least one measurable lesion according to RECIST v1.1 criteria
- Adequate bone marrow reserve and organ function
- Participants of childbearing potential must agree to use highly reliable contraceptive methods during the study and for at least 12 weeks after the last dose
You will not qualify if you...
- History of two or more primary malignancies within 5 years before informed consent
- Received anti-tumor treatment within 4 weeks or within 5 half-lives of prior treatment before dosing
- Use of other unmarketed investigational drugs or therapies within 4 weeks before dosing
- Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before dosing, or planned elective surgery during the study
- Vaccination with attenuated live vaccines within 4 weeks before dosing
- Treatment with systemic corticosteroids within 14 days before dosing
- Central nervous system metastasis
- Uncontrolled third-space fluid accumulation
- Serious heart or brain blood vessel diseases
- Severe lung disease affecting breathing
- Active infection needing systemic therapy
- Known allergy or delayed allergic reaction to study drugs or components
- Drug abuse or medical/psychiatric conditions interfering with study participation
- Known alcohol or drug dependence
- Pregnant or breastfeeding women, or those planning to conceive
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
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
7
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