Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07265622

First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors

Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-12-29

200

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.

CONDITIONS

Official Title

First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Pathologically confirmed advanced solid tumors
  • Disease progression after most recent treatment regimen
  • At least one measurable lesion according to RECIST v1.1
  • Provision of archival tumor tissue or fresh biopsy
  • Adequate blood, liver, and kidney function
  • Compliance with contraceptive requirements
Not Eligible

You will not qualify if you...

  • Other concurrent malignancies within the past 3 years, except treated carcinoma in situ
  • Active, untreated, or symptomatic central nervous system metastasis
  • Effusions requiring frequent drainage
  • Active autoimmune diseases except type I diabetes, hypothyroidism, or non-systemic autoimmune diseases
  • Severe respiratory disease requiring hospitalization in the last 28 days
  • Significant uncontrolled cardiovascular disease or events within 6 months prior to study drug
  • Poorly controlled blood glucose with fasting levels above 10 mmol/L
  • History of allogeneic stem cell or organ transplant
  • Active HIV or hepatitis B/C infection or infections requiring systemic intravenous treatment within 14 days
  • Unresolved toxicities from prior anti-cancer therapies above CTCAE grade 1 except alopecia and endocrinopathies
  • Recent treatments requiring washout periods including specific cancer therapies, surgeries, investigational therapies, systemic immunosuppressives, or use of strong CYP3A4 inhibitors/inducers
  • Known hypersensitivity to 7MW4911 or its components
  • Abuse of narcotic or psychoactive drugs
  • Pregnant or breastfeeding women
  • Any other conditions judged unsuitable by the investigator

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 Municipality, China, 200032

Actively Recruiting

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Research Team

L

Lei Cong

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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