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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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)

About the study

A Study of Emi-Le in Participants with Solid Tumors

What is being tested

Sponsor: Day One Biopharmaceuticals, Inc. · Participants: 360 · Started: Aug 15, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05377996

Locations in the U.S.

ArizonaMayo Clinic Comprehensive Cancer Center, Phoenix
CaliforniaUC Irvine Health-Chao Family Comprehensive Cancer Center, Orange
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
UCLA David Geffen School of Medicine, Division of Hematology/Oncology, Santa Monica
FloridaMayo Clinic - Jacksonville, Jacksonville
Florida Cancer Specialists, Sarasota
Moffitt Cancer Center, Tampa
GeorgiaWinship Cancer Institute, Emory University, Atlanta
IllinoisNorthwestern University, Chicago
MassachusettsBeth Israel Deaconess Medical Center, Boston
Dana-Farber Cancer Institute, Boston
MichiganHenry Ford Health Hospital, Detroit
MinnesotaMayo Clinic - Rochester, Rochester
NevadaComprehensive Cancer Centers of Nevada, Las Vegas
New YorkICHAN School of Medicine at Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
New York University Langone Health, New York
OklahomaStephenson Cancer Center Oklahoma University Health, Oklahoma City
South DakotaAvera Cancer Institute, Sioux Falls
TennesseeSarah Cannon Research Institute (SCRI), Nashville
TexasTexas Oncology, P.A., Dallas
MD Anderson, Houston
UtahHuntsman Cancer Institute, Salt Lake City
VirginiaNEXT Oncology Virginia, Fairfax
WashingtonFred Hutchinson Cancer Center, Seattle
Summit Cancer Centers, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.