Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05514717

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

Led by Mersana Therapeutics · Updated on 2025-07-11

162

Participants Needed

14

Research Sites

218 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has recurrent or metastatic solid tumors with HER2 expression and has disease progression after treatment, is intolerant to treatment, or is contraindicated with available anti-cancer therapies known to confer benefit, based on investigator's judgement. Note: Participants must have HER2 positivity per the results of their most recent tumor tissue testing, defined as IHC 3+ or IHC 2+ in combination with in situ hybridization (ISH)+. Participants with ERBB2-activating mutations or ERBB2 gene amplification in the absence of HER2 positivity are considered ineligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Participant must have measurable disease as defined by RECIST version 1.1.
  • Participant has fresh tumor biopsy tissue available for submission to central laboratory. If obtaining fresh tumor tissue is medically contraindicated, archival tumor tissue can be submitted following written approval of the request by the study Medical Monitor. Samples must be obtained after the participant's most recent HER2-targeting therapy unless determined to be medically contraindicated after discussion with the medical monitor.
Not Eligible

You will not qualify if you...

  • • Participant is receiving immunosuppressive doses of systemic medications, (doses >10 mg/day prednisone or equivalent) that cannot be discontinued for at least 2 weeks before the first dose and during study drug treatment administration. Note: physiologic hormone replacement therapy is an exception.

  • Participant has received prior treatment targeting STING pathway.

  • Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within the last 2 years, expect for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the breast or the cervix. Participants with an additional malignancy that has a low risk for recurrence may be eligible after discussion with the study Medical Monitor.

  • Participants have untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.

    1. Participants are eligible if CNS metastases are adequately treated and participants are neurologically stable for at least 2 weeks prior to enrollment.
    2. In addition, participants must be either off corticosteroids, or on a stable/decreasing dose of ≤ 10 mg prednisone daily (or equivalent).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

University of South California

Los Angeles, California, United States, 90033

Actively Recruiting

2

University of California Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

3

Stanford University Medical Center

Stanford, California, United States, 94305

Actively Recruiting

4

AdventHealth Celebration

Celebration, Florida, United States, 34747

Actively Recruiting

5

Emory Healthcare, Emory Clinic

Atlanta, Georgia, United States, 30322

Actively Recruiting

6

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

7

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

8

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

9

New York University Medical Oncology Associates

New York, New York, United States, 10016

Actively Recruiting

10

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

11

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

12

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43212

Actively Recruiting

13

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

Actively Recruiting

14

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

J

June Buchanan

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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