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A Study of Emiltatug Ledadotin (Emi-Le) for Solid Tumors

This study is testing a drug called Emiltatug Ledadotin (Emi-Le) in people with solid tumors that have returned or spread. Emi-Le is a targeted therapy, meaning it's designed to attack cancer cells specifically. The study will look at how safe Emi-Le is, what side effects it might cause, and if it can shrink tumors. You may be able to join if you have certain solid tumors, like triple-negative breast cancer, ovarian cancer, or endometrial cancer, and your cancer has come back or is advanced. Researchers will also need a sample of your tumor tissue. The study aims to find the best dose of Emi-Le and see how well it works. The study is currently recruiting up to 360 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve up to 360 participants and has three parts: finding the right dose, testing safety and effectiveness, and a larger Phase 2 part.
What's involved
Participants will receive Emi-Le intravenously (through a vein). You will need to provide tumor tissue, either existing or from a new biopsy.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor adverse events for up to 3 years and measure how well the treatment works for approximately 3 years.

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NCT05377996

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Day One Biopharmaceuticals, Inc.
~360 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Emi-Le

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation)
Measured over 17 months
+2 more outcomes measured

Conditions

Triple Negative Breast Cancer
Breast Cancer
Endometrial Cancer
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Adenoid Cystic Carcinoma

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Adenoid Cystic CarcinomaBreast CarcinomaEndometrial CarcinomaFallopian Tube CarcinomaMalignant Ovarian NeoplasmMalignant Peritoneal NeoplasmSolid Neoplasm

Where it's being run

26 sites across 17 states
California3
Florida3
New York3
Massachusetts2
Texas2
Washington2
Arizona1
Georgia1

Study leadership

  • Robert Burger, MD · STUDY_DIRECTOR · Day One Biopharmaceuticals, Inc.

Who to contact

Day One Clinical Trials Information
[email protected]
1-650-484-0899
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:

Exclusion

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)

What this trial measures

  • 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