RecruitingPhase 1Phase 2NCT06985355

A Study of MHB046C Injection in Patients With Advanced Solid Tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors

Sponsor

Minghui Pharmaceutical (Hangzhou) Ltd

Enrollment

200 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Cancer

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

Min Age: 18 Years

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 Criteria13

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 (unless asymptomatic, no edema, stable ≥4 weeks without steroids), 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:
Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.
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.
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

DRUGMHB046C

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.