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Experimental HER2 cancer drug trial halted early

NCT ID NCT05514717

Disease control Sponsor: Day One Biopharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This was an early-phase study testing a new drug called XMT-2056 in people with advanced solid tumors that have a protein called HER2. The trial aimed to find a safe dose and check for side effects. It was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XMT-2056 (given intravenously)
What this could lead to
If it had succeeded, this could have pointed toward a new treatment option for advanced HER2-positive cancers.
What could go wrong
The trial was terminated early, so results are limited. It was a very early phase 1 study, so safety and effectiveness were not established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

57 people

The number who actually took part.

Started

Jan 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion 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).

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma gastric cancer HER2 positive breast carcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2 low breast cancer HER2-positive breast cancer HER2-positive colorectal cancer HER2-positive gastric cancer HER2-positive non-small cell lung cancer HER2-positive tumors

Contacts and locations

Locations

  • AdventHealth Celebration

    Celebration, Florida, 34747, United States

  • Emory Healthcare, Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • New York University Medical Oncology Associates

    New York, New York, 10016, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43212, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of South California

    Los Angeles, California, 90033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.