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RECRUITING Phase 1

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

NCT06752681 · View on ClinicalTrials.gov ↗

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

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06752681

The ClinicalTrials.gov registry entry for NCT06752681 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Day One Biopharmaceuticals, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06752681 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Florida, Texas, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06752681?

The interventions under investigation include: DAY301 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06752681?

This trial is sponsored by Day One Biopharmaceuticals, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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