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

Recruiting now · Phase 1/Phase 2

Conditions studied: Triple Negative Breast Cancer, Breast Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Adenoid Cystic Carcinoma

In brief

A Study of Emi-Le in Participants with Solid Tumors

Key facts

Study ID

NCT05377996

Run by

Day One Biopharmaceuticals, Inc.

People needed

360

Starts

2022-08-15

Expected to finish

2027-12-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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