A Study of MHB009C in Patients With Advanced Solid Tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB009C for Injection in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Solid Tumor
• Intervention / Treatment: Drug: MHB009C for Injection

Detailed Description

This first-in-human clinical trial of MHB009C comprises two parts: a dose escalation phase and a dose expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB009C in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). In this phase, additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.

Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the dose expansion phase. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the safety and efficacy of MHB009C monotherapy in patients with specific types of advanced solid tumors.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: CMO/ Senior Vice President of R&D; Phone Number: +86 0571-86963293; Email: jwshi@minghuipharma.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201419
      • Recruiting
      • Fudan University Shanghai Cancer Center, Shanghai
      • Contact: Ethics Committee; Phone Number: +86 021-64175590-85033; Email: JJYIN555@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
6. At least one measurable lesion per RECIST v1.1 criteria or one bone.
7. Adequate bone marrow reserve and 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, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
5. Severe bone damage caused by bone metastasis of prostate cancer.
6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
7. Severe lung disease affecting pulmonary function.
8. Vaccinated within 4 weeks before dosing.
9. Active systemic infection requiring treatment within 7 days before dosing.
10. Serious cardiovascular or cerebrovascular diseases.
11. Uncontrolled third-space effusions not suitable for enrollment.
12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
14. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
15. Known alcohol or drug dependence.
16. Pregnant or breastfeeding women, or individuals planning to conceive. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MHB009C (Phase I: Dose escalation); There are seven escalating dose cohorts.	Drug: MHB009C for Injection; IV administration of MHB009C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Experimental: MHB009C (Phase II: Dose expansion); The recommended dose from the dose-escalation stage and other potential doses will be further explored.	Drug: MHB009C for Injection; IV administration of MHB009C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB009C	To determine the MTD for further evaluation of IV administration of MHB009C monotherapy in subjects with advanced solid tumors.	Up to day 21 from the first dose.
(Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1	To determine the recommended Phase II dose (RP2D) of MHB009C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DOR) determined by investigators according to RECIST v1.1	DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Disease control rate (DCR) determined by investigators according to RECIST v1.1	Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Overall survival (OS)	OS was defined as the time from random assignment or first dose to death from any cause.	Baseline up until death up to approximately 5 years
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to treatment suspension, discontinuation	AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0].	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.
Area Under the Concentration-Time Curve (AUC)	The PK parameters at different time points include: Area Under the Concentration-Time Curve (AUC)	From pre-dose to 22 days after the first dose.
Maximum Plasma Concentration (Cmax)	The PK parameters at different time points include: Maximum Plasma Concentration (Cmax)	From pre-dose to 22 days after the first dose.
Proportion of subjects who develop anti-MHB009C antibodies (ADA).	Immunogenicity	From pre-dose to 30 days post end of treatment.

Collaborators and Investigators

• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: MHB009C-A-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No