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NCT05377996PHASE1, PHASE2Recruiting

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

Day One Biopharmaceuticals, Inc.

Start Date

8/15/2022

Completion Date

12/1/2027

Summary

A Study of Emi-Le in Participants with Solid Tumors

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

DRUG

Emi-Le

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Conditions

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

Locations

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona 85054

United States

UC Irvine Health-Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California 94158

United States

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

Santa Monica, California 90404

United States

Mayo Clinic - Jacksonville

Jacksonville, Florida 32224

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

Northwestern University

Chicago, Illinois 60611

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Henry Ford Health Hospital

Detroit, Michigan 48202

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169

United States

New York University Langone Health

New York, New York 10016

United States

ICHAN School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Stephenson Cancer Center Oklahoma University Health

Oklahoma City, Oklahoma 73104

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee 37203

United States

Texas Oncology, P.A.

Dallas, Texas 75251

United States

MD Anderson

Houston, Texas 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States

Fred Hutchinson Cancer Center

Seattle, Washington 09109

United States

Summit Cancer Centers

Spokane, Washington 99208

United States