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RECRUITING
NCT06752681
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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