A Study of MHB009C in Patients With Advanced Solid Tumors

NCT07326488 | Recruiting Phase 1

• 1 other identifier: MHB009C-A-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (2)

• (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 Outcomes (7)

• Duration of response (DOR) 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

• Disease control rate (DCR) 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

• Overall survival (OS)

  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

  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)

  From pre-dose to 22 days after the first dose.

Study Arms (2)

MHB009C (Phase I: Dose escalation)

EXPERIMENTAL

There are seven escalating dose cohorts.

Drug: MHB009C for Injection

MHB009C (Phase II: Dose expansion)

EXPERIMENTAL

The recommended dose from the dose-escalation stage and other potential doses will be further explored.

Drug: MHB009C for Injection

Interventions

MHB009C for Injection DRUG

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.

MHB009C (Phase I: Dose escalation); MHB009C (Phase II: Dose expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center, Shanghai

Shanghai, Shanghai Municipality, 201419, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

CMO/ Senior Vice President of R&D

CONTACT

+86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 8, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)