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Triple Negative Breast CancerPhase 1/2NCT05377996

A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors

A Phase 1/2 study testing Emi-Le in people with Triple Negative Breast Cancer and Breast Cancer, run by Day One Biopharmaceuticals, Inc. at 26 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Study of Emi-Le in Participants with Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Emi-Le
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
26 sitesUnited States
Study dates
15 Aug 2022to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • All participants with TNBC
  • Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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)

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Day One Clinical Trials Information contact

1-650-484-0899

clinicaltrials@dayonebio.com

26 sites in 1 country

United States26 sites, 26 recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

    Kevin Kalinsky, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Gerburg Wulf, MD

    Gerburg Wulf, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Antonio Giordano, MD, PhD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Patricia Robinson, MD

    Patricia Robinson, MD

    Recruiting

  • Texas Oncology, P.A.

    Dallas, Texas, 75251

    Joyce O'Shaughnessy, MD

    Recruiting

  • Henry Ford Health Hospital

    Detroit, Michigan, 48202

    Amy Weise, MD

    Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031

    Alex Spira, MD, PhD

    Recruiting

  • MD Anderson

    Houston, Texas, 77030

    Funda Meric-Bernstam

    Funda Meric-Bernstam

    Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

    Pooja Advani, MD

    Pooja Advani, MD

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

    Liawaty Ho, MD

    Liawaty Ho, MD

    Recruiting

  • Sarah Cannon Research Institute (SCRI)

    Nashville, Tennessee, 37203

    Erika P Hamilton, MD

    Recruiting

  • New York University Langone Health

    New York, New York, 10016

    Nancy Chan, MD

    Recruiting

  • ICHAN School of Medicine at Mount Sinai

    New York, New York, 10029

    Amy Tiersten

    Amy Tiersten

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Nour Abuhadra, MD

    Recruiting

  • Stephenson Cancer Center Oklahoma University Health

    Oklahoma City, Oklahoma, 73104

    Debra Richardson, MD

    Debra Richardson, MD

    Recruiting

  • UC Irvine Health-Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Ritesh Parajuli

    Ritesh Parajuli

    Recruiting

  • Mayo Clinic Comprehensive Cancer Center

    Phoenix, Arizona, 85054

    Felipe Batalini, MD

    Felipe Batalini, MD

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

    Roberto Leon-Ferre, MD

    Roberto Leon-Ferre, MD

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Kristen Kelley, MD

    Kristen Kelley, MD

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Laura Huppert, MD

    Laura Huppert, MD

    Recruiting

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

    Santa Monica, California, 90404

    Nicholas McAndrew, MD

    Nicholas McAndrew, MD

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Judy Wang

    Judy Wang

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 09109

    Jennifer Specht, MD

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    David C. Starks, MD

    David C. Starks, MD

    Recruiting

  • Summit Cancer Centers

    Spokane, Washington, 99208

    Arvind Chaudhry, MD, PhD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Hyo Han, MD

    Hyo Han, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors

A Study of Emi-Le in Participants with Solid Tumors

Read the detailed description

This first-in-human (FIH) study will test the safety, side effects, and antitumor activity of a drug called Emi-Le ((Emiltatug Ledadotin, formerly XMT-1660). A side effect is anything a drug does to the body besides treating the disease.

Participants in the study will have cancer that has come back after a period of time during which the cancer could not be detected (recurrent), spread in the body near where it started (advanced) or spread through the body (metastatic).

The study will have three parts. The first part called Dose Escalation, will find out how much Emi-Le should be given to participants. The second part called Dose Expansion, will use the dose found in the first part to find out how safe Emi-Le is and if it works to treat solid tumors. The third part, the Phase 2 part of the trial, called EMBLEM-1, will find out if Emi-Le works to treat aggressive Adenoid Cystic Carcinoma and continue to check how safe Emi-Le is.

Being tested
Emi-Le
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emi-LeDrug

    Emi-Le will be administered through a vein in your arm or port catheter (intravenously)

Study groups in NCT05377996
Study groupRoleWhat they receive
Emi-LeExperimentalSingle arm Emi-Le alone (monotherapy)
Receives: Drug: Emi-Le

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation)

    Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Emi-Le

    Measured: 17 months

  2. Incidence of adverse events (Dose Escalation and Dose Expansion)

    Assess the safety and tolerability of Emi-Le by determining the number of patients with adverse events from date of first dose to 60 days post last dose

    Measured: 3 years

  3. Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1)

    The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: approximately 3 years

Secondary outcomes (8)

  1. Objective Response Rate (ORR) (Dose Escalation)

    The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to approximately 3 years

  2. Duration of response (DOR) (Dose Escalation, Dose Expansion, and EMBLEM-1)

    The time from when response criteria are first met until disease progression or death in participants who achieve a complete or partial response

    Measured: Up to approximately 3 years

  3. Maximum observed plasma concentration of Emi-Le and payload (Cmax) (Dose Escalation and Dose Expansion)

    Cmax is the maximum concentration determined from the measured concentrations in plasma

    Measured: Up to approximately 3 years

  4. Area under the concentration-time curve of Emi-Le and payload (AUC) (Dose Escalation and Dose Expansion)

    Area under the concentration-time curve for the last measurable concentration (AUC0-last) will be assessed as data permit

    Measured: Up to approximately 3 years

  5. Antidrug antibodies (ADAs) and neutralizing antibodies (NAbs) (Dose Escalation, Dose Expansion, and EMBLEM-1)

    Assess the development of ADAs and NAbs to Emi-Le

    Measured: Up to approximately 3 years

  6. Assess the overall survival (OS) of patients treated with Emi-Le (Dose Escalation, Dose Expansion, and EMBLEM-1)

    The time from the date of first dose of study treatment to the date of death due to any cause

    Measured: Up to approximately 3 years

  7. Incidence of adverse events (EMBLEM-1)

    Assess the safety and tolerability of Emi-Le by determining the number of patients with adverse events from date of first dose to 60 days post last dose

    Measured: 3 years

  8. Progression-free survival (PFS) (EMBLEM-1)

    The time from the date of first dose of study treatment until the first date at which disease progression is objectively documented or date of death due to any cause, whichever occurs first

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start15 Aug 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05377996
Sponsor's protocol ID
MER-XMT-1660-1
Status last verified
Jun 2026
First submitted
2 May 2022
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Toader D, Fessler SP, Collins SD, Conlon PR, Bollu R, Catcott KC, Chin CN, Dirksen A, Du B, Duvall JR, Higgins S, Kozytska MV, Bellovoda K, Faircloth C, Lee D, Li F, Qin L, Routhier C, Shaw P, Stevenson CA, Wang J, Wongthida P, Ter-Ovanesyan E, Ditty E, Bradley SP, Xu L, Yin M, Yurkovetskiy AV, Mosher R, Damelin M, Lowinger TB. Discovery and Preclinical Characterization of XMT-1660, an Optimized B7-H4-Targeted Antibody-Drug Conjugate for the Treatment of Cancer. Mol Cancer Ther. 2023 Sep 5;22(9):999-1012. doi: 10.1158/1535-7163.MCT-22-0786.

    PubMed 37294948

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Emi-Le in people with Triple Negative Breast Cancer and Breast Cancer, run by Day One Biopharmaceuticals, Inc. at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Day One Clinical Trials Information (1-650-484-0899, clinicaltrials@dayonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation) (time frame: 17 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05377996, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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