A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
NCT ID: NCT05514717
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
162 participants
INTERVENTIONAL
2023-01-24
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XMT-2056
XMT-2056 alone (monotherapy)
XMT-2056
XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)
Interventions
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XMT-2056
XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Mersana Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Brad Sumrow, MD
Role: STUDY_DIRECTOR
Mersana Therapeutics
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Anthony El-Khoueiry, MD
Role: primary
Nicholas McAndrew, MD
Role: primary
Christopher Chen, MD
Role: primary
Guru Sonpavde, MD
Role: primary
Manali Bhave, MD
Role: primary
Samuel Klempner, MD
Role: primary
Jailan Elayoubi, MD
Role: primary
Martin Gutierrez, MD
Role: primary
Kristen Spencer, MD
Role: primary
Deborah Doroshow, MD
Role: primary
Ezra Rosen, MD
Role: primary
Arya Roy, MD
Role: primary
Erika P Hamilton, MD
Role: primary
Ecaterina Dumbrava, MD
Role: primary
Other Identifiers
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MER-XMT-2056-1
Identifier Type: -
Identifier Source: org_study_id
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