Actively Recruiting
An Open-label Phase II Clinical Study of MHB036C for Injection Combined With MHB039A for Injection 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of two drugs, MHB036C and MHB039A, in patients with advanced breast cancer or other advanced malignant solid tumors. This open-label Phase II trial aims to assess the safety, tolerability, how the body processes the drugs, and the early effects of this combination therapy. The study includes patients with locally advanced or metastatic solid tumors who have measurable lesions and meet specific health criteria. The trial has two main parts: a safety run-in phase and an indication expansion phase. The safety run-in phase involves dose escalation and may include an optional pharmacokinetic expansion to better understand how the drugs behave in the body at safe dose levels. After evaluating safety and early results, the indication expansion phase will further assess the combination's safety and effectiveness in different patient groups. Participants receive both MHB036C and MHB039A through intravenous infusions every three weeks. Participants will be closely monitored throughout the study, which can last up to about five years. Researchers will evaluate tumor response, disease control, progression-free survival, overall survival, and any side effects using established criteria and assessments. Blood samples will be taken to study drug levels over time. The study will track participants until disease progression, death, loss to follow-up, or withdrawal, ensuring thorough safety and efficacy monitoring during this period.
CONDITIONS
Brief 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 and signs informed consent
- Age between 18 and 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 agree to use highly reliable contraception 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 prior to consent
- Received anti-tumor treatment within 4 weeks or within 5 half-lives of previous 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 requiring elective surgery during the study
- Vaccination with attenuated live vaccines within 4 weeks before dosing
- Treatment with systemic corticosteroids within 14 days before dosing
- Presence of central nervous system metastasis
- Uncontrolled third-space effusion
- Serious cardiovascular or cerebrovascular diseases
- Severe lung disease affecting pulmonary function
- Active infection requiring systemic therapy
- Known hypersensitivity or delayed allergic reaction to the investigational products
- 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 - Duration varies based on dose escalation and pharmacokinetic assessments
Participants receive MHB036C combined with MHB039A by intravenous administration in a safety run-in phase including dose escalation and optional pharmacokinetic expansion.
Repeated visits every 3 weeks for dosing and assessments
Duration - Up to approximately 5 years or until disease progression, death, withdrawal, or lost to follow-up
Participants receive MHB036C combined with MHB039A by intravenous administration in the indication expansion phase to evaluate efficacy and safety in advanced breast cancer or other solid tumors.
Infusions every 3 weeks with regular assessments during treatment
Duration - Up to approximately 5 years after treatment ends
Participants are monitored for safety, survival, and tumor response after treatment ends.
Visits as needed for safety and survival monitoring
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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