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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
DAY301 is an investigational small molecule being developed by Day One Biopharmaceuticals for the treatment of locally advanced or metastatic solid tumors. It is in Phase 1 clinical development and is designed to target PTK7, a protein target. It has not been established as a marketed therapy.
DAY301 is being studied for use in adults with locally advanced or metastatic solid tumors. The Phase 1 trial enrolls participants 18 years and older and evaluates safety, tolerability, pharmacokinetics, and antitumor activity. Its use in this setting remains investigational and is available only through clinical research.
DAY301 targets PTK7, a protein target. PTK7 is the molecular target named for this small molecule, and the Phase 1 program is biomarker selected, meaning trial enrollment is guided by biomarker criteria. The trial is designed to assess how the drug behaves in participants whose tumors meet those criteria.
DAY301 is being developed by Day One Biopharmaceuticals, Inc., which trades under the ticker DAWN. The company is the sponsor of the Phase 1 study evaluating the drug in locally advanced or metastatic solid tumors in the United States and Canada.
DAY301 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial is currently recruiting, with a planned enrollment of 300 participants and no completed trials reported for the program.
DAY301 is being evaluated in trial NCT06752681, titled a study of the safety, tolerability, pharmacokinetics, and antitumor activity of DAY301 in participants with locally advanced or metastatic solid tumors. The Phase 1 trial is recruiting, is uncontrolled, is not randomized or double blind, and plans to enroll 300 participants across the United States and Canada.