A Study of MHB046C Injection in Patients With Advanced Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Advanced Solid Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Minghui Pharmaceutical (Hangzhou) Ltd · Industry
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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), and preliminary efficacy of MHB046C monotherapy.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 years, no restriction on gender.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Estimated life expectancy ≥ 3 months.
5. Able to understand and comply w…
Inclusion Criteria:
1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 years, no restriction on gender.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Estimated life expectancy ≥ 3 months.
5. Able to understand and comply with the study protocol and follow-up procedures.
6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
7. At least one measurable lesion per RECIST v1.1 criteria.
8. Adequate organ function.
Exclusion Criteria:
1. History of ≥2 primary malignancies within 5 years prior to informed consent.
2. 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.
3. Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.
4. Severe lung disease affecting pulmonary function.
5. Active systemic infection requiring treatment within 7 days before dosing.
6. Serious cardiovascular or cerebrovascular diseases
7. Uncontrolled third-space effusions not suitable for enrollment:
8. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.
9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
11. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
12. Known alcohol or drug dependence.
13. Pregnant or breastfeeding women, or individuals planning to conceive.
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