TerminatedPhase 1

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

Stopped: Development discontinued.

United States57 participantsStarted 2023-01-24

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing its planned phases — do you know why it was stopped, and what that might mean for the safety or promise of XMT-2056 as a treatment option?
2Since this was a Phase 1 trial primarily designed to measure dose-limiting toxicities and adverse events, what do you know about the safety signals that emerged, and how does that compare to other HER2-targeted treatments I might be eligible for?
3Given that this trial is no longer recruiting and has been terminated, are there other active clinical trials targeting HER2 that you think would be worth exploring for my specific cancer type?
4My cancer is HER2-positive — based on what was learned from this trial before it was stopped, does it change how you're thinking about which HER2-targeted therapies might be the best next step for me?
5Are there currently approved standard-of-care HER2-targeted treatments for my diagnosis that might be a more established path to consider while we look at whether any other trials are a good fit?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of dose-limiting toxicities (DLTs) associated with XMT-2056 during the first cycle of treatment (Dose Escalation)

Timeframe: 15 months

Incidence of adverse events (Dose Escalation and Dose Expansion)

Timeframe: 3 years

Objective Response Rate (ORR) (Dose Expansion)

Timeframe: 3 years

Trial details

NCT IDNCT05514717

SponsorDay One Biopharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-22

View on ClinicalTrials.gov More HER2-positive Breast Cancer trials