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)
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation) — 17 months Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Emi-Le
Incidence of adverse events (Dose Escalation and Dose Expansion) — 3 years 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
Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1) — approximately 3 years 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
Trial sites (26)
Facility
City
Region
Status
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
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.
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