Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07326488

A Study of MHB009C in Patients With Advanced Solid Tumors

Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-04-13

200

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Study of MHB009C in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agrees to participate and signs informed consent.
  • Age 18 years or older, any gender.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Estimated life expectancy of at least 3 months.
  • Histologically or cytologically confirmed advanced solid tumors refractory to or intolerant of standard therapy, or with no standard treatment options.
  • At least one measurable lesion per RECIST v1.1 or one bone lesion.
  • Adequate bone marrow reserve and organ function.
Not Eligible

You will not qualify if you...

  • History of two or more primary malignancies within 5 years prior to consent.
  • Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
  • Use of other unmarketed investigational drugs or therapies within 4 weeks before first dose.
  • Brain, bone marrow, leptomeningeal, brainstem metastases, or spinal cord compression.
  • Severe bone damage from prostate cancer bone metastasis.
  • Unresolved adverse reactions from previous anti-tumor treatments worse than Grade 1 by CTCAE 5.0.
  • Severe lung disease affecting lung 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.
  • Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
  • Known hypersensitivity to investigational product or components.
  • Drug abuse or medical/psychiatric conditions interfering with participation.
  • Known alcohol or drug dependence.
  • Pregnant or breastfeeding women, or planning to conceive.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center, Shanghai

Shanghai, Shanghai Municipality, China, 201419

Actively Recruiting

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Research Team

C

CMO/ Senior Vice President of R&D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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