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

Last updated: July 10, 2025
Sponsor: Mersana Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

XMT-2056

Clinical Study ID

NCT05514717
MER-XMT-2056-1
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has recurrent or metastatic solid tumors with HER2 expression and hasdisease progression after treatment, is intolerant to treatment, or iscontraindicated with available anti-cancer therapies known to confer benefit, basedon investigator's judgement. Note: Participants must have HER2 positivity per theresults of their most recent tumor tissue testing, defined as IHC 3+ or IHC 2+ incombination with in situ hybridization (ISH)+. Participants with ERBB2-activatingmutations or ERBB2 gene amplification in the absence of HER2 positivity areconsidered 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 centrallaboratory. If obtaining fresh tumor tissue is medically contraindicated, archivaltumor tissue can be submitted following written approval of the request by the studyMedical Monitor. Samples must be obtained after the participant's most recentHER2-targeting therapy unless determined to be medically contraindicated afterdiscussion with the medical monitor.

Exclusion

Exclusion Criteria:

  • • Participant is receiving immunosuppressive doses of systemic medications, (doses >10 mg/day prednisone or equivalent) that cannot be discontinued for at least 2weeks 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 (includingsurgery, systemic therapy, and radiation) within the last 2 years, expect foradequately treated basal cell or squamous cell skin cancer or carcinoma in situ ofthe breast or the cervix. Participants with an additional malignancy that has a lowrisk for recurrence may be eligible after discussion with the study Medical Monitor.

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

  1. Participants are eligible if CNS metastases are adequately treated andparticipants are neurologically stable for at least 2 weeks prior toenrollment.

  2. In addition, participants must be either off corticosteroids, or on astable/decreasing dose of ≤ 10 mg prednisone daily (or equivalent).

Study Design

Total Participants: 162
Treatment Group(s): 1
Primary Treatment: XMT-2056
Phase: 1
Study Start date:
January 24, 2023
Estimated Completion Date:
April 30, 2027

Study Description

The first-in-human (FIH) study of XMT-2056 is a Phase 1, open-label study of XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2. The XMT-2056 monotherapy trial will consist of dose escalation (DES) and expansion (EXP) parts.

DES will be the dose-finding portion of the study to assess the safety and tolerability of XMT-2056 and determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D). The RP2D will be determined based on the totality of the clinical data, including safety and preliminary anti-tumor effect, PK, and relevant biomarker data.

Connect with a study center

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of South California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Active - Recruiting

  • AdventHealth Celebration

    Celebration, Florida 34747
    United States

    Active - Recruiting

  • Emory Healthcare, Emory Clinic

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • New York University Medical Oncology Associates

    New York, New York 10016
    United States

    Active - Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • START San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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