Actively Recruiting
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
Eligibility Criteria
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.
You will not qualify if you...
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• 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.
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Participant has received prior treatment targeting STING pathway.
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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.
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Participants have untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
- Participants are eligible if CNS metastases are adequately treated and participants are neurologically stable for at least 2 weeks prior to enrollment.
- 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
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
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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