Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07192107

A Study of MHB042C in Patients With Advanced Solid Tumors

Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-04-09

200

Participants Needed

1

Research Sites

200 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 MHB042C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB042C monotherapy.

CONDITIONS

Official Title

A Study of MHB042C 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
  • ECOG performance status of 0-1
  • Estimated life expectancy of at least 3 months
  • Histologically or cytologically confirmed advanced solid tumors refractory, intolerant, or without 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 before consent
  • Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first dose
  • Use of other unmarketed investigational drugs or therapies within 4 weeks before first dose
  • Presence of brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression
  • Severe bone damage from prostate cancer bone metastasis
  • Unrecovered adverse reactions from prior anti-tumor treatment worse than CTCAE Grade 1
  • Severe lung disease affecting lung function
  • Vaccination 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 or delayed allergic reaction to the investigational product or components
  • Drug abuse or medical/psychiatric conditions interfering with participation or results
  • Known alcohol or drug dependence
  • Pregnant, breastfeeding, 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

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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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