A Study of MHB118C Injection in Patients With Advanced Solid Tumors
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB118C Injection in Patients With Advanced Solid Tumors
Minghui Pharmaceutical (Hangzhou) Ltd
200 participants
Mar 31, 2025
INTERVENTIONAL
Conditions
Summary
This is a first-in-human, open-label, multicenter Phase I study of MHB118C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB118C monotherapy.
Eligibility
Inclusion Criteria8
- 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 Criteria11
- 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, 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.
- 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.
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Interventions
IV administration by Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07045454