Status:
RECRUITING
A Study of MHB046C Injection in Patients With Advanced Solid Tumors
Lead Sponsor:
Minghui Pharmaceutical (Hangzhou) Ltd
Conditions:
Advanced Solid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK)...
Detailed Description
This first-in-human clinical trial of MHB046C comprises two parts: a dose escalation phase and an indication expansion phase. The dose escalation phase is an open-label, multicenter study including do...
Eligibility Criteria
Inclusion
- Voluntarily agrees to participate in the study and signs the informed consent form.
- Age ≥ 18 years, no restriction on gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy ≥ 3 months.
- Able to understand and comply with the study protocol and follow-up procedures.
- Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
- At least one measurable lesion per RECIST v1.1 criteria.
- Adequate organ function.
Exclusion
- History of ≥2 primary malignancies within 5 years prior to informed consent.
- Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
- Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.
- Severe lung disease affecting pulmonary function.
- Active systemic infection requiring treatment within 7 days before dosing.
- Serious cardiovascular or cerebrovascular diseases
- Uncontrolled third-space effusions not suitable for enrollment:
- Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.
- 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 its components.
- Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
- Known alcohol or drug dependence.
- Pregnant or breastfeeding women, or individuals planning to conceive.
Key Trial Info
Start Date :
July 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2031
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06985355
Start Date
July 17 2025
End Date
May 1 2031
Last Update
September 18 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China