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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 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.

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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.

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

FieldValue
Enrollment Target 254 participants
Start Date 2024-11-18
Est. Completion 2028-12
Phase Phase 1

Sponsor

Day One Biopharmaceuticals

5 total trials

What the Registry Record Tells You About NCT06752681

The ClinicalTrials.gov registry entry for NCT06752681 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 224-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (13% higher). The listed sponsor is Day One Biopharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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