A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
A Phase 1/2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
1 other identifier
interventional
360
1 country
26
Brief Summary
A Study of Emi-Le in Participants with Solid Tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Longer than P75 for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 29, 2026
June 1, 2026
4.5 years
May 2, 2022
June 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation)
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Emi-Le
17 months
Incidence of adverse events (Dose Escalation and Dose Expansion)
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
3 years
Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1)
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
approximately 3 years
Secondary Outcomes (8)
Objective Response Rate (ORR) (Dose Escalation)
Up to approximately 3 years
Duration of response (DOR) (Dose Escalation, Dose Expansion, and EMBLEM-1)
Up to approximately 3 years
Maximum observed plasma concentration of Emi-Le and payload (Cmax) (Dose Escalation and Dose Expansion)
Up to approximately 3 years
Area under the concentration-time curve of Emi-Le and payload (AUC) (Dose Escalation and Dose Expansion)
Up to approximately 3 years
Antidrug antibodies (ADAs) and neutralizing antibodies (NAbs) (Dose Escalation, Dose Expansion, and EMBLEM-1)
Up to approximately 3 years
- +3 more secondary outcomes
Study Arms (1)
Emi-Le
EXPERIMENTALSingle arm Emi-Le alone (monotherapy)
Interventions
Emi-Le will be administered through a vein in your arm or port catheter (intravenously)
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
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
Related Publications (1)
Toader D, Fessler SP, Collins SD, Conlon PR, Bollu R, Catcott KC, Chin CN, Dirksen A, Du B, Duvall JR, Higgins S, Kozytska MV, Bellovoda K, Faircloth C, Lee D, Li F, Qin L, Routhier C, Shaw P, Stevenson CA, Wang J, Wongthida P, Ter-Ovanesyan E, Ditty E, Bradley SP, Xu L, Yin M, Yurkovetskiy AV, Mosher R, Damelin M, Lowinger TB. Discovery and Preclinical Characterization of XMT-1660, an Optimized B7-H4-Targeted Antibody-Drug Conjugate for the Treatment of Cancer. Mol Cancer Ther. 2023 Sep 5;22(9):999-1012. doi: 10.1158/1535-7163.MCT-22-0786.
PMID: 37294948DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Burger, MD
Day One Biopharmaceuticals, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 17, 2022
Study Start
August 15, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 29, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share