TerminatedPhase 1NCT05514717
Official study titleA Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Study summary
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
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Key things to know
Main goalTreatment
This describes the study’s primary purpose.
What is being studiedXMT-2056
The study team can explain what participation involves.
Who it may be forNon-small cell lung cancer (NSCLC) · HER2 · Recurrent or relapsed
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 18, 2026 · Source: ClinicalTrials.gov
Is enrollment open?Terminated
Ask the study team to confirm whether enrollment is open.
What kind of study?Phase 1
Interventional
Where is it offered?14 U.S. locations
Locations may change over time.
Who runs it?Day One Biopharmaceuticals, Inc.
Study sponsor
Study overview
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Day One Biopharmaceuticals, Inc.
- Interventions being studied
- Drug: XMT-2056
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How this study is categorized
These labels come from structured fields and exact terms in the public record.
Public criteria
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Requirements people may need to meetInclusion criteria
- 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.
Reasons someone may not be able to joinExclusion criteria
- 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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
Study sites
U.S. locations
- University of South CaliforniaLos Angeles, California
- University of California Los AngelesLos Angeles, California
- Stanford University Medical CenterStanford, California
- AdventHealth CelebrationCelebration, Florida
- Emory Healthcare, Emory ClinicAtlanta, Georgia
- Massachusetts General HospitalBoston, Massachusetts
- Karmanos Cancer InstituteDetroit, Michigan
- Hackensack University Medical CenterHackensack, New Jersey
- New York University Medical Oncology AssociatesNew York, New York
- Icahn School of Medicine at Mount SinaiNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- The Ohio State University Comprehensive Cancer CenterColumbus, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 18, 2026. Always confirm current availability with the study team.