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

Stopped early · Phase 1

Conditions studied: HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Non-Small Cell Lung Cancer, HER2-positive Colorectal Cancer, HER2-positive Tumors, HER2 Low Breast Cancer

In brief

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

Key facts

Study ID

NCT05514717

Run by

Day One Biopharmaceuticals, Inc.

People needed

57

Starts

2023-01-24

Expected to finish

2026-05-22

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• • 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.
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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