Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DAY301 · 1 trial · 1 indication
To evaluate adverse events (AEs) considered dose limiting toxicities that occur in the first cycle of treatment (within a DLT observation period).
The type, incidence, and severity of AEs and SAEs will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
The frequency at which dose interruptions occur during dose-escalation
The duration of dose interruptions that occur during dose-escalation.
The frequency at which dose reductions occur during dose-escalation.
The duration of dose reductions that occur during dose-escalation.
Objective response rate based on best overall response (BOR) will be assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
The type, incidence, and severity of AEs and SAEs will be determined using the NCI CTCAE v5.0.
The frequency at which dose interruptions occur during dose-expansion.
The duration of dose interruptions that occur during dose-expansion.
The frequency at which dose reductions occur during dose-expansion.
The duration of dose reductions that occur during dose-expansion.
| Arm | Type | Description |
|---|---|---|
| DAY301 intravenous (IV) infusion | EXPERIMENTAL | DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts. |
| Name | Type | Description |
|---|---|---|
| DAY301 | DRUG | DAY301 will be administered as IV infusion |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors of the following histologies: * Ovarian cancer * Esophageal squamous cell carcinoma * Triple-negative breast cancer * Non-small cell lung cancer * Small cell lung cancer * Head and neck ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
DAY301 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
DAY301 is being developed by Day One Biopharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol DAWN.
DAY301 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. The ongoing Phase 1 trial is actively recruiting participants.
DAY301 is being studied in a Phase 1 clinical trial with the identifier NCT06752681. This trial is evaluating the safety, tolerability, pharmacokinetics, and antitumor activity of DAY301 in participants with locally advanced or metastatic solid tumors.
No, DAY301 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials, and its safety and efficacy have not yet been established.