Actively Recruiting
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd · 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 MHB048C in this first-in-human, open-label, multicenter Phase I/II clinical trial for patients with advanced solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics (how the drug moves through the body), and early signs of effectiveness of MHB048C when given alone. It also seeks to find the maximum tolerated dose and explore effects in specific tumor types including metastatic castration-resistant prostate cancer (mCRPC). The trial has two parts: a dose escalation phase and a dose expansion phase. During the dose escalation phase, patients receive increasing doses of MHB048C to determine safety and the best dose. There are seven escalating dose groups, with some patients enrolled to study pharmacokinetics and dose-limiting toxicities. The dose expansion phase follows, focusing on further evaluating safety and effectiveness of the recommended dose and other doses in patients with mCRPC or other advanced tumors. MHB048C is given by intravenous infusion every two or three weeks, and treatment continues until unacceptable side effects or disease progression occur. Participants will be closely monitored through regular assessments including tumor scans following RECIST criteria to measure response, safety checks for adverse events, and blood tests to study drug levels and immune reactions. The study tracks outcomes such as tumor response, disease control, progression-free survival, overall survival, and side effect severity for up to about five years. Pharmacokinetic data and immunogenicity will be collected early after dosing. Participants may remain in the study for several years with ongoing evaluations, ensuring thorough observation of treatment effects and safety over time.
CONDITIONS
Brief Title
A Study of MHB048C 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, 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 advanced solid tumors refractory or intolerant to standard therapy or without standard treatment options
- At least one measurable lesion per RECIST v1.1 or 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 prior to consent
- Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic/endocrine/immunotherapy within 4 weeks before first study dose
- Use of other investigational drugs or therapies within 4 weeks before first investigational drug dose
- Presence of brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression
- Severe bone damage from prostate cancer metastasis
- Unrecovered adverse reactions from previous anti-tumor treatments worse than CTCAE Grade 1
- Severe lung disease affecting lung function
- Vaccination 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 allergic reaction to study drug or components
- Drug abuse or medical/psychiatric conditions interfering with participation
- Known alcohol or drug dependence
- Pregnant or breastfeeding women or those 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 disease progression or unacceptable toxicity
Participants receive intravenous MHB048C every 2 or 3 weeks. Treatment continues until unacceptable toxicities occur or disease progression is confirmed.
Infusions every 2 or 3 weeks with regular assessments
Duration - Up to approximately 5 years
Participants are monitored for safety, efficacy, and survival outcomes up to approximately 5 years after treatment ends.
Periodic visits for disease and safety monitoring
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 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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