Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DAY101 · 1 trial · 1 indication
A DLT is defined as an AE assessed as at least possibly related to the study medication, which occurs during Cycle 1 (typically 28 days following the first dose of DAY101)
| Arm | Type | Description |
|---|---|---|
| DAY101 (formerly TAK-580, MLN2480) BSA </= 1.5m^2 | EXPERIMENTAL | Phase I Part B BSA \</= 1.5m\^2 * Patients (\< 25 years) with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) or solid tumors) associated with activation of the RAS/RAF/MEK/ERK pathway will be eligible with the exception of patients with NF1 * Study treatment cycle lasts 28 days, oral, once a week |
| DAY101 (formerly TAK-580, MLN2480) BSA > 1.5m^2 | EXPERIMENTAL | Phase I Part B BSA \> 1.5m\^2 * Patients (\< 25 years) with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) or solid tumors) associated with activation of the RAS/RAF/MEK/ERK pathway will be eligible with the exception of patients with NF1 * Study treatment cycle lasts 28 days, oral, once a week |
| Name | Type | Description |
|---|---|---|
| DAY101 | DRUG | 28 day cycle, oral, once per week |
Inclusion Criteria: * Participants must meet the following criteria on screening examination to be eligible to participate in the study: * Phase I * Pediatric patients with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) ...
DAY101 is an investigational small molecule being studied for the treatment of low-grade glioma, a type of brain tumor. It is currently in clinical development for this oncology indication.
DAY101 is a small molecule designed to target specific molecular pathways involved in tumor growth. It is being evaluated in biomarker-selected patients with low-grade glioma, indicating that its activity is linked to particular genetic alterations.
DAY101 is being developed by Day One Biopharmaceuticals, Inc., a company traded under the ticker symbol DAWN. The company is focused on advancing this investigational therapy for patients with low-grade glioma.
DAY101 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
DAY101 has been studied in a Phase 1 clinical trial with the identifier NCT03429803, titled 'DAY101 In Gliomas and Other Tumors.' This trial, which enrolled 44 participants with low-grade glioma, has been completed.
DAY101 is the primary name for this investigational drug. No alternative names have been established for it in the available information.