Actively Recruiting
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd ยท Updated on 2026-04-09
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MHB042C, a new drug, in patients with advanced solid tumors in this first-in-human Phase I/II study. The study aims to assess the safety, tolerability, how the drug is processed in the body (pharmacokinetics), and early signs of effectiveness of MHB042C given alone. It includes patients whose tumors are resistant to or have no standard treatment options. The study has two parts: a dose escalation phase and a dose expansion phase. In the dose escalation phase, participants receive increasing doses of MHB042C given intravenously every two or three weeks to find the maximum tolerated dose. After determining safe doses and collecting initial data, the dose expansion phase will further evaluate safety and effectiveness in specific tumor types. Participants continue treatment until unacceptable side effects or disease progression occur. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST criteria, safety monitoring for side effects, and blood tests to study drug levels and immune response. The primary outcomes include identifying dose-limiting toxicities and tumor response rates. Secondary outcomes evaluate duration of response, overall survival, and other safety and pharmacokinetic parameters. Participants may be followed for up to five years to monitor long-term outcomes and safety.
CONDITIONS
Brief Title
A Study of MHB042C 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
- ECOG performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced solid tumors refractory or intolerant to standard therapy or lacking standard treatment options
- At least one measurable lesion according to RECIST v1.1 or one 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 before 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 metastasis
- Unresolved adverse reactions from previous anti-tumor treatments higher than CTCAE Grade 1
- Severe lung disease affecting pulmonary function
- Vaccinated 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 first dose
- Known hypersensitivity or delayed allergic reaction to the investigational product or 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 IV administration of MHB042C every 2 or 3 weeks. Treatment continues until unacceptable toxicities or confirmed disease progression occur.
Regular visits every 2 to 3 weeks for treatment administration and assessments
Duration - Up to approximately 5 years
Participants are monitored for safety, efficacy, and survival outcomes after treatment ends, up to approximately 5 years.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
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
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