Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Emi-Le · 1 trial · 7 indications
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Emi-Le
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
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
| Arm | Type | Description |
|---|---|---|
| Emi-Le | EXPERIMENTAL | Single arm Emi-Le alone (monotherapy) |
| Name | Type | Description |
|---|---|---|
| Emi-Le | DRUG | Emi-Le will be administered through a vein in your arm or port catheter (intravenously) |
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 f...
Emi-Le is an investigational small molecule being studied for the treatment of triple negative breast cancer and other solid tumors. It is also being evaluated in breast cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cavity cancer, and adenoid cystic carcinoma. It is not yet approved for any indication.
Emi-Le is being developed by Day One Biopharmaceuticals, Inc., which trades under the ticker DAWN. The company is the sponsor of the clinical program evaluating Emi-Le in solid tumors, including triple negative breast cancer.
Emi-Le is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program is currently recruiting participants and is designed to evaluate Emi-Le in patients with solid tumors, including triple negative breast cancer.
Emi-Le is being studied in the Phase 1 trial NCT05377996, titled A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors. The trial is recruiting, has an estimated enrollment of 360 participants, and is being conducted in the United States in adults aged 18 years and older.
Yes, Emi-Le is the short name for emiltatug ledadotin. The Phase 1 trial NCT05377996 refers to the agent as emiltatug ledadotin (Emi-Le), so both names identify the same investigational small molecule being developed by Day One Biopharmaceuticals.
Yes, the Emi-Le Phase 1 trial NCT05377996 is biomarker selected, meaning enrollment is guided by a biomarker. The study is an uncontrolled, open-label Phase 1 trial recruiting adults with solid tumors, including triple negative breast cancer, across sites in the United States.