Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07216560

First-in-human Study of 7MW4911 in GI Cancer

Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2026-04-30

200

Participants Needed

5

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.

CONDITIONS

Official Title

First-in-human Study of 7MW4911 in GI Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 and above
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Advanced or metastatic gastrointestinal cancer that has progressed after standard treatments
  • Disease progression after the 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 active malignancy within the past 3 years except adequately treated carcinoma in situ
  • Active, untreated, or symptomatic central nervous system metastasis
  • Effusions requiring frequent drainage
  • Active autoimmune disease except type I diabetes, hypothyroidism, or autoimmune diseases not requiring systemic treatment
  • 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 infection requiring intravenous treatment within 14 days prior to study drug
  • Unresolved toxicities from prior anti-cancer therapies except alopecia and endocrinopathies
  • Prior treatment with Topo-I payload ADC or CDH17 targeting therapy
  • Recent cancer therapy within 5 half-lives or 21 days prior to study drug
  • Major surgeries within 28 days prior to study drug
  • Investigational therapy within 28 days prior to study drug
  • Systemic immunosuppressive treatment within 28 days prior to study drug, except physiological or topical glucocorticoids
  • Use of strong CYP3A4 inhibitors or inducers
  • Known hypersensitivity to 7MW4911 or formulation components
  • Abuse of narcotic or psychoactive drugs
  • Pregnant or breastfeeding women
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States, 34952

Actively Recruiting

2

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

3

START

Long Island City, New York, United States, 11042

Actively Recruiting

4

START Moutain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

5

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

Loading map...

Research Team

S

Shaona Cai

CONTACT

W

Wenhui Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here