A Study of MHB009C in Patients With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Malignant Solid Tumor

In brief

This is a first-in-human, open-label, multicenter Phase I/II study of MHB009C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB009C monotherapy.

Key facts

Study ID

NCT07326488

Run by

Minghui Pharmaceutical (Hangzhou) Ltd

People needed

200

Starts

2026-03-17

Expected to finish

2029-03-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. -

You may not qualify if…

• 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.
• Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
• Severe bone damage caused by bone metastasis of prostate cancer.
• Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
• Severe lung disease affecting pulmonary function.
• Vaccinated within 4 weeks before dosing.
• Active systemic infection requiring treatment within 7 days before dosing.
• Serious cardiovascular or cerebrovascular diseases.
• Uncontrolled third-space effusions not suitable for enrollment.
• 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. -

Where it is running

• Fudan University Shanghai Cancer Center, Shanghai — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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