Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB118C Injection in Patients With Advanced Solid Tumors
Led by Minghui Pharmaceutical (Hangzhou) Ltd ยท Updated on 2025-07-01
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MHB118C injection in adults with advanced malignant solid tumors that are resistant to or have no standard treatment options. This first-in-human, open-label Phase I study aims to assess the safety, tolerability, pharmacokinetics, and initial effectiveness of MHB118C given alone. The trial includes patients with tumors that can be measured by standard criteria and who have a good performance status and life expectancy of at least three months. The study has two parts: a dose escalation phase where participants receive increasing doses of MHB118C every three weeks through intravenous infusion to find the maximum tolerated dose, followed by an indication expansion phase to further evaluate safety and effectiveness in specific tumor types. Patients will continue treatment until unacceptable side effects or confirmed disease progression occur. Additional patients may be enrolled in pharmacokinetic expansion cohorts after dose-limiting toxicity evaluations. Participants will undergo regular assessments including safety monitoring, pharmacokinetic blood tests, and tumor response evaluations according to RECIST criteria. Researchers will measure dose-limiting toxicities, adverse events, antibody levels, immune response, tumor response rates, disease control, progression-free survival, and overall survival over up to five years. The study involves ongoing follow-up until progression, withdrawal, or death, ensuring comprehensive long-term monitoring.
CONDITIONS
Brief Title
A Study of MHB118C Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent
- Aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Estimated life expectancy of at least 3 months
- Able to understand and follow study protocol and procedures
- Histologically or cytologically confirmed advanced solid tumors refractory or intolerant to standard therapy or with no standard treatment options
- At least one measurable lesion per RECIST v1.1 criteria
- Adequate organ function
You will not qualify if you...
- History of two or more primary malignancies within the past 5 years
- Chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic/endocrine/immunotherapy within 4 weeks before first study dose
- Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression
- Severe lung disease affecting breathing
- Active systemic infection requiring treatment within 7 days before dosing
- Serious cardiovascular or cerebrovascular diseases
- Uncontrolled third-space effusions not suitable for enrollment
- Known allergy or delayed allergic reaction to the investigational product or its components
- Drug abuse or medical/psychiatric conditions interfering with study participation or results
- Known alcohol or drug dependence
- Pregnant, breastfeeding, 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 unacceptable toxicities or disease progression, up to approximately 5 years
Participants receive MHB118C injections every 3 weeks and continue treatment until unacceptable toxicities occur or disease progression is confirmed.
Visits every 3 weeks for treatment administration with additional assessments as scheduled
Duration - Up to 5 years after treatment completion
Participants are monitored for safety, pharmacokinetics, immunogenicity, and efficacy outcomes after treatment ends.
Periodic follow-up visits up to 5 years
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
Research Team
V
VP of R&D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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