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DAY301

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |Day One Biopharmaceuticals, Inc.|Last Updated: Oct 10, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment254
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06752681To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 254 — — Nov 18, 2024Dec 1, 2028Oct 10, 202512 United States, Canada
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Study Endpoints
Primary Endpoints
Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs)
Within 21 days of first infusion (Day 1)

To evaluate adverse events (AEs) considered dose limiting toxicities that occur in the first cycle of treatment (within a DLT observation period).

Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) or serious AEs (SAEs)
through the duration of treatment, up to approximately 12 months

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.

Phase 1a: Dose Escalation: Frequency of dose interruptions
through the duration of treatment, up to approximately 12 months

The frequency at which dose interruptions occur during dose-escalation

Phase 1a: Dose Escalation: Duration of dose interruptions
through the duration of treatment, up to approximately 12 months

The duration of dose interruptions that occur during dose-escalation.

Phase 1a: Dose Escalation: Frequency of dose reductions
through the duration of treatment, up to approximately 12 months

The frequency at which dose reductions occur during dose-escalation.

Phase 1a: Dose Escalation: Duration of dose reductions
through the duration of treatment, up to approximately 12 months

The duration of dose reductions that occur during dose-escalation.

Phase 1b: Dose Expansion: Objective response rate
through the duration of treatment, up to approximately 12 months-up

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).

Phase 1b: Dose Expansion: Number of participants reporting AEs and SAEs
through the duration of treatment, up to approximately 12 months

The type, incidence, and severity of AEs and SAEs will be determined using the NCI CTCAE v5.0.

Phase 1b: Dose Expansion: Frequency of dose interruptions
through the duration of treatment, up to approximately 12 months

The frequency at which dose interruptions occur during dose-expansion.

Phase 1b: Dose Expansion: Duration of dose interruption
through the duration of treatment, up to approximately 12 months

The duration of dose interruptions that occur during dose-expansion.

Phase 1b: Dose Expansion: Frequency of dose reductions
through the duration of treatment, up to approximately 12 months

The frequency at which dose reductions occur during dose-expansion.

Phase 1b: Dose Expansion: Duration of dose reductions
through the duration of treatment, up to approximately 12 months

The duration of dose reductions that occur during dose-expansion.

Secondary Endpoints
Phase 1a and Phase 1b: Maximum concentration (Cmax) of DAY301
Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: time to Cmax (Tmax) of DAY301
Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: area under the curve (AUC) of DAY301
Varying timepoints through the duration of treatment, up to approximately 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DAY301 intravenous (IV) infusionEXPERIMENTALDAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts.
Interventions
NameTypeDescription
DAY301DRUGDAY301 will be administered as IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

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 ...

Countries:United StatesCanada
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06752681primaryCompletionDate: changed
LOWMay 24, 2026NCT06752681studyFirstPostDate: changed