Tests MHB048C drug in adults with advanced solid tumors
Tests MHB048C, a new injected drug, in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: A Study of MHB048C in Patients With Advanced Solid Tumors
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Minghui Pharmaceutical (Hangzhou) Ltd
- Trial code
- NCT07192120
- Record updated
- 9 April 2026
- Original description
This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.Read full original descriptionShow less
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors
This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.
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; 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 or one bone; Adequate bone marrow reserve and organ function. -.
Exclusion: History of ≥2 primary malignancies within 5 years prior to informed consent; Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose; Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug; Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1; Vaccinated within 4 weeks before dosing; Active systemic infection requiring treatment within 7 days before dosing; 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; Known alcohol or drug dependence; Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression; Severe bone damage caused by bone metastasis of prostate cancer; Severe lung disease affecting pulmonary function; Serious cardiovascular or cerebrovascular diseases; Drug abuse or other medical/psychiatric condition that may interfere with study participation or results; Uncontrolled third-space effusions not suitable for enrollment; Pregnant or breastfeeding women, or individuals planning to conceive. -.