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
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)
- Brain metastasesOutrightexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- HepaticOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - Prior malignancyOutrightexclusion
within 2 years
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County