Phase
Condition
N/ATreatment
XMT-2056
Clinical Study ID
Ages > 18 All Genders
Study Summary
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.
Participants are eligible if CNS metastases are adequately treated andparticipants are neurologically stable for at least 2 weeks prior toenrollment.
In addition, participants must be either off corticosteroids, or on astable/decreasing dose of ≤ 10 mg prednisone daily (or equivalent).
Study Design
Study Description
Connect with a study center
University of California Los Angeles
Los Angeles, California 90095
United StatesActive - Recruiting
University of South California
Los Angeles, California 90033
United StatesActive - Recruiting
Stanford University Medical Center
Stanford, California 94305
United StatesActive - Recruiting
AdventHealth Celebration
Celebration, Florida 34747
United StatesActive - Recruiting
Emory Healthcare, Emory Clinic
Atlanta, Georgia 30322
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
New York University Medical Oncology Associates
New York, New York 10016
United StatesActive - Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43212
United StatesActive - Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
START San Antonio
San Antonio, Texas 78229
United StatesSite Not Available

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