NCT05377996 A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
| NCT ID | NCT05377996 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Day One Biopharmaceuticals, Inc. |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 360 participants in total. It began in 2022-08-15 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Study of Emi-Le in Participants with Solid Tumors
Eligibility Criteria
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)
Contact & Investigator
Robert Burger, MD
STUDY DIRECTOR
Day One Biopharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT05377996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05377996 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05377996 currently recruiting?
Yes, NCT05377996 is actively recruiting participants. Contact the research team at clinicaltrials@dayonebio.com for enrollment information.
Where is the NCT05377996 trial being conducted?
This trial is being conducted at Phoenix, United States, Orange, United States, San Francisco, United States, Santa Monica, United States and 11 additional locations.
Who is sponsoring the NCT05377996 clinical trial?
NCT05377996 is sponsored by Day One Biopharmaceuticals, Inc.. The principal investigator is Robert Burger, MD at Day One Biopharmaceuticals, Inc.. The trial plans to enroll 360 participants.
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