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Trial NCT05377996

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

Phase
Phase 1/2
Sponsor
Day One Biopharmaceuticals, Inc.
Conditions
Triple Negative Breast Cancer; Breast Cancer; Endometrial Cancer; Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Adenoid Cystic Carcinoma
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Recurrent or advanced solid tumor and has disease * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1Performance status * 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.Prior malignancy * Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.Brain metastases * Prior B7-H4 targeted treatment. * History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.Hepatic * 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 diseaseCardiac * Active keratitis (inflammation of the cornea of the eye)

Restrictions found (5)

Recruiting in Massachusetts

  • Beth Israel Deaconess Medical Center · Boston, Suffolk County
  • Dana-Farber Cancer Institute · Boston, Suffolk County