Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07045454

A Study of MHB118C Injection in Patients With Advanced Solid Tumors

Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2025-07-01

200

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a first-in-human, open-label, multicenter Phase I study of MHB118C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB118C monotherapy.

CONDITIONS

Official Title

A Study of MHB118C Injection 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Estimated life expectancy of at least 3 months
  • Able to understand and follow study procedures
  • Histologically or cytologically confirmed advanced solid tumors refractory or intolerant to standard therapy, or with no standard treatment options
  • At least one measurable lesion per RECIST v1.1 criteria
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • History of 2 or more primary cancers within 5 years before consent
  • Received chemotherapy within 3 weeks or radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy) before first dose
  • Received biologic, endocrine, or immunotherapy within 4 weeks before first dose
  • Presence of brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression
  • Severe lung disease affecting lung function
  • Active systemic infection requiring treatment within 7 days before dosing
  • Serious cardiovascular or cerebrovascular diseases
  • Uncontrolled third-space fluid buildup
  • Known allergy to the investigational product or its components
  • Drug abuse or psychiatric conditions interfering with participation
  • Known alcohol or drug dependence
  • Pregnant or 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

Shanghai Chest Hospital

Shanghai, China

Actively Recruiting

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Research Team

V

VP of R&D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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