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New drug XMT-1660 enters first human tests for Hard-to-Treat cancers

NCT ID NCT05377996

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called XMT-1660 in about 319 people with advanced solid tumors, including breast, ovarian, and endometrial cancers. The main goals are to find the safest dose and check for side effects. Researchers will also see if the drug shrinks tumors. This is a first-in-human trial, so the main focus is safety.

Why investors are watching

Day One Biopharmaceuticals is running a first-in-human phase 1/2 trial of its drug emiltatug ledadotin (Emi-Le) in 360 people with solid tumors. For a small company, this early data will show whether the drug is safe and whether it shrinks tumors, which could determine the drug's future and the company's direction.

If it works: If the trial shows the drug controls tumors with manageable side effects, Day One could advance it to later-stage testing and build a pipeline beyond its current focus. A positive readout may also attract larger partners or licensing deals.

If it fails: Most first-in-human cancer drugs fail to show enough benefit or prove too toxic, and this trial could end early or produce weak data. A failure or delay would leave Day One with few options and could hurt its credibility with investors.

AI-written from the trial record. Speculative, and not investment advice.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

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: * Recurrent or advanced solid tumor and has disease * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1. * Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1 * Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria: 1. All participants with TNBC 2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases. Exclusion Criteria: * Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed. * Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment. * Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix. * Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis. * Prior B7-H4 targeted treatment. * History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases. * Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator. * Clinically significant cardiovascular disease * Active keratitis (inflammation of the cornea of the eye)

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Conditions

The condition(s) this trial relates to.

adenoid cystic carcinoma breast cancer breast neoplasm endometrial cancer endometrium neoplasm fallopian tube cancer fallopian tube neoplasm neoplasm ovarian cancer primary peritoneal carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Adenoid cystic carcinoma Breast cancer Endometrial cancer Fallopian tube cancer Ovarian cancer Primary peritoneal cavity cancer Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Comprehensive Cancer Centers of Nevada

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 09109, United States

  • Henry Ford Health Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • ICHAN School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • New York University Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Sarah Cannon Research Institute (SCRI)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Stephenson Cancer Center Oklahoma University Health

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Summit Cancer Centers

    RECRUITING

    Spokane, Washington, 99208, United States

  • Texas Oncology, P.A.

    RECRUITING

    Dallas, Texas, 75251, United States

  • UC Irvine Health-Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

  • UCLA David Geffen School of Medicine, Division of Hematology/Oncology

    RECRUITING

    Santa Monica, California, 90404, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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