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, also known as Emiltatug Ledadotin, is an investigational small molecule being studied for the treatment of solid tumors, including Triple Negative Breast Cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
The molecular target of Emi-Le has not been disclosed in available information. It is a small molecule being evaluated for its potential antitumor activity in solid tumors, including Triple Negative Breast Cancer.
Emi-Le is being developed by Day One Biopharmaceuticals, Inc., a company publicly traded under the ticker symbol DAWN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
Emi-Le is currently in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing trial is recruiting participants to assess its safety and preliminary efficacy in solid tumors.
Emi-Le is being studied in a Phase 1 clinical trial with the identifier NCT05377996, titled 'A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors.' This trial is recruiting participants in the United States and has an estimated enrollment of 360 patients.
Yes, Emi-Le is the same as Emiltatug Ledadotin. Emi-Le is a shortened name used for the drug, while Emiltatug Ledadotin is the full name. Both refer to the same investigational small molecule being developed for solid tumors.