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To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor: Day One Biopharmaceuticals, Inc.
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 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.
Official title: A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2024-11-18
Completion Date
2028-12
Last Updated
2025-10-10
Healthy Volunteers
No
Conditions
Interventions
DAY301
DAY301 will be administered as IV infusion
Locations (12)
Site: 001-058
New Haven, Connecticut, United States
Site: 001-063
Lake Mary, Florida, United States
Site: 001-064
Sarasota, Florida, United States
Site: 001-060
Indianapolis, Indiana, United States
Site: 001-059
Grand Rapids, Michigan, United States
Site: 001-039
New York, New York, United States
Site: 001-073
Oklahoma City, Oklahoma, United States
Site: 001-065
Nashville, Tennessee, United States
Site: 001-069
Houston, Texas, United States
Site: 001-057
San Antonio, Texas, United States
Site: 011-013
Vancouver, British Columbia, Canada
Site: 011-005
Toronto, Ontario, Canada