๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-21

To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors (NCT06752681)

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

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Day One Biopharmaceuticals, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Site: 001-058 โ€” New Haven, Connecticut

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

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

๐Ÿ“ž Contact the Study Coordinator

Phone: (650) 484-0899

Email: clinicaltrials@dayonebio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—