RecruitingPhase 1Phase 2NCT07216560

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

A Phase I/II Study of 7MW4911 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Advanced Colorectal Cancer and Other Advanced Gastrointestinal Tumors


Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

200 participants

Start Date

Jan 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study is testing a new drug called 7MW4911 in people with advanced gastrointestinal (GI) cancers (such as stomach, colorectal, esophageal, or other GI cancers) whose cancer has progressed after standard treatments. **You may be eligible if...** - You are 18 or older and have advanced or metastatic gastrointestinal cancer - Your cancer has progressed after receiving standard-of-care treatment - You have at least one measurable tumor on scans - You have adequate blood, liver, and kidney function - You are reasonably functional (ECOG 0–1) with at least 3 months life expectancy **You may NOT be eligible if...** - You have active, untreated brain metastases - You have an active autoimmune disease (except well-controlled conditions like type 1 diabetes or hypothyroidism) - You have active HIV, hepatitis B, or hepatitis C infection - You have had a bone marrow or organ transplant - You have significant uncontrolled heart disease - You have poorly controlled blood sugar - You are pregnant or breastfeeding - You have had prior treatment with a similar drug (CDH17-targeting therapy) or a topoisomerase I payload antibody-drug conjugate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG7MW4911

study drug


Locations(5)

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

START

Long Island City, New York, United States

START Moutain Region

West Valley City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07216560