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NCT06752681 · ClinicalTrials.gov registry record · Phase 1
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Day One Biopharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 254
- Enrollment target
- 12
- Study locations
NCT06752681: Recruiting Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Day One Biopharmaceuticals.
NCT06752681 is a Phase 1 study of Advanced or Metastatic Solid Tumors that is actively recruiting participants, run by Day One Biopharmaceuticals. The registered enrollment target is 254 participants, above the 224-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (13% higher). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06752681, a Phase 1 study of Advanced or Metastatic Solid Tumors, is actively recruiting participants, sponsored by Day One Biopharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 254 participants
- Enrollment target
- 12
- Study locations
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 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.
Primary Outcome
To evaluate adverse events (AEs) considered dose limiting toxicities that occur in the first cycle of treatment (within a DLT observation period).
Conditions Studied
Interventions
- DRUG DAY301
Study Locations (12)
Florida
- Site: 001-063 - Lake Mary
- Site: 001-064 - Sarasota
Texas
- Site: 001-069 - Houston
- Site: 001-057 - San Antonio
Connecticut
- Site: 001-058 - New Haven
Indiana
- Site: 001-060 - Indianapolis
Michigan
- Site: 001-059 - Grand Rapids
New York
- Site: 001-039 - New York
Oklahoma
- Site: 001-073 - Oklahoma City
Tennessee
- Site: 001-065 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2024-11-18 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT06752681 shows while recruiting
NCT06752681 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 224-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which DAY301 is the first listed.
NCT06752681 lists 12 locations in 10 states (Florida, Texas, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06752681 about?
NCT06752681 is a clinical study titled "To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors". 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 participa...
What is the current status of trial NCT06752681?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 254 participants. The study started on 2024-11-18. Estimated completion is 2028-12.
What conditions does trial NCT06752681 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT06752681?
The interventions under investigation include: DAY301 (DRUG).
Who is sponsoring clinical trial NCT06752681?
This trial is sponsored by Day One Biopharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06752681 being conducted?
This trial has 12 study locations across Connecticut, Florida, Indiana, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06752681's enrollment target sits among peer trials
254 5th of 19 higher than 15 of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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