To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors

NCT06752681 · tracked via the Priya Life Science Canada tracker

Sponsor

Day One Biopharmaceuticals, Inc

Phase

Phase 1

Started

2024-11-18

Last updated

2026-07-22

Condition(s) studied

Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

DAY301

DAY301: DAY301 will be administered as IV infusion

Study summary

This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate (ADC) in participants with advanced or metastatic solid tumors. The study comprises of 2 phases: Phase 1a dose escalation where participants will be administered DAY301 at escalating dose levels to assess safety and tolerability, and to determine the maximum tolerated dose (MTD) and/or the recommended dose (RD); In Phase 1b dose expansion, DAY301 will be evaluated in dose expansion cohorts.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 squamous cell carcinoma * Cervical squamous cell carcinoma * Endometrial cancers (Participants must have been previously treated with standard of care systemic therapy, have refused standard therapy, or have no standard therapy available). * Availability of tumor tissue sample (either an archival specimen or a fresh biopsy) at screening * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitors (Phase 1b). * Phase 1b disease-specific exclusion criteria: 1. Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas) 2. Cohort 2: Nasopharyngeal primary tumors. 3. Cohort 3: Ovarian cancer that progressed \>6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (PR or complete response \[CR\]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease) .- History of small bowel obstruction requiring hospitalization within 3 months prior to the first dose of study treatment. * Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management, or new onset within 4 weeks prior to the first dose of study treatment. Patients with an indwelling catheter may be considered eligible, after consultation with the medical monitor. * Active or progressing brain metastases or evidence of leptomeningeal disease. * Persistent toxicities from previous systemic antineoplastic treatments of Grade \>1, excluding alopecia and vitiligo. * Systemic antineoplastic therapy within five half-lives or 4 weeks, whichever is shorter, prior to first dose of study treatment, including investigational agents. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

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) and 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
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.

Trial sites (11)

Facility	City	Region	Status
Site: 001-058	New Haven	Connecticut	Recruiting
Site: 001-064	Sarasota	Florida	Recruiting
Site: 001-060	Avon	Indiana	Recruiting
Site: 001-059	Grand Rapids	Michigan	Recruiting
Site: 001-039	New York	New York	Recruiting
Site: 001-073	Oklahoma City	Oklahoma	Recruiting
Site: 001-065	Nashville	Tennessee	Recruiting
Site: 001-069	Houston	Texas	Recruiting
Site: 001-057	San Antonio	Texas	Recruiting
Site: 011-013	Vancouver	British Columbia	Recruiting
Site: 011-005	Toronto	Ontario	Recruiting

More Day One Biopharmaceuticals, Inc. trials in Canada

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors Recruiting

DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) Active, not recruiting

Other trials for the same condition

A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001) Active, not recruiting

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06752681 on ClinicalTrials.gov ↗ ← All trials in Canada