MHB046C: IV administration of MHB046C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Study 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), and preliminary efficacy of MHB046C monotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
I (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB046C — Up to day 21 from the first dose To determine the MTD for further evaluation of IV administration of MHB046C in subjects with advanced solid tumors.
II (Dose-Expansion Stage): ORR determined by investigators according to RECIST v1.1 — Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years To determine the recommended Phase II dose (RP2D) of MHB046C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.
Trial sites (1)
Facility
City
Region
Status
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Recruiting
More Minghui Pharmaceutical (Hangzhou) Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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