RecruitingPhase 1NCT05514717

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2

A Phase 1, First-in-Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2


Sponsor

Mersana Therapeutics

Enrollment

162 participants

Start Date

Jan 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests XMT-2056, a new antibody-drug conjugate, in patients with advanced or metastatic solid tumors that are HER2-positive (meaning the cancer cells have high levels of a protein called HER2 on their surface). It is an early-phase study to evaluate safety and find the right dose. **You may be eligible if...** - You have been diagnosed with a solid tumor that has come back or spread and tests positive for HER2 (IHC 3+ or IHC 2+ with positive ISH test) - You have received prior standard treatments and your cancer has continued to progress - You are in good general health (ECOG 0 or 1) - You have measurable tumors that can be tracked on scans - You are willing to provide a tumor biopsy sample **You may NOT be eligible if...** - Your tumor is HER2-positive only through gene mutation or amplification without the IHC/ISH positivity criteria - You have uncontrolled brain metastases - You have significant lung, heart, or kidney problems - You are pregnant or breastfeeding - You have received prior treatment with this specific drug 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

DRUGXMT-2056

XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)


Locations(14)

University of South California

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

AdventHealth Celebration

Celebration, Florida, United States

Emory Healthcare, Emory Clinic

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

New York University Medical Oncology Associates

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05514717


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