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Clinical Trials in Israel / NCT05377996
Recruiting Phase 1/2

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

NCT05377996 · tracked via the Priya Life Science Israel tracker
Phase
Phase 1/2
Started
2022-08-15
Last updated
2026-06-29

Condition(s) studied

Triple Negative Breast CancerBreast CancerEndometrial CancerOvarian CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerAdenoid Cystic Carcinoma

Investigational drug(s) / intervention(s)

Emi-Le

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

Study summary

A Study of Emi-Le in Participants with Solid Tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Mayo Clinic Comprehensive Cancer Center Phoenix Arizona Recruiting
UC Irvine Health-Chao Family Comprehensive Cancer Center Orange California Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
UCLA David Geffen School of Medicine, Division of Hematology/Oncology Santa Monica California Recruiting
Mayo Clinic - Jacksonville Jacksonville Florida Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
Northwestern University Chicago Illinois Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Health Hospital Detroit Michigan Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Comprehensive Cancer Centers of Nevada Las Vegas Nevada Recruiting
New York University Langone Health New York New York Recruiting
ICHAN School of Medicine at Mount Sinai New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Stephenson Cancer Center Oklahoma University Health Oklahoma City Oklahoma Recruiting
Avera Cancer Institute Sioux Falls South Dakota Recruiting
Sarah Cannon Research Institute (SCRI) Nashville Tennessee Recruiting
Texas Oncology, P.A. Dallas Texas Recruiting
MD Anderson Houston Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Summit Cancer Centers Spokane Washington Recruiting

More Day One Biopharmaceuticals, Inc. trials in Israel

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05377996 on ClinicalTrials.gov ↗ ← All trials in Israel