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NCT04065555 · ClinicalTrials.gov registry record · Early Phase 1

Intratumoral Microdosing of TAK-981 in Head and Neck Cancer

A Early Phase 1 study of Head and Neck Cancer, sponsored by Presage Biosciences.

Completed
Registry status
Early Phase 1
Development phase
12
Enrollment target
6
Study locations

NCT04065555 is a Early Phase 1 study of Head and Neck Cancer that has completed, run by Presage Biosciences. The registered enrollment target is 12 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT04065555, a Early Phase 1 study of Head and Neck Cancer, has completed, sponsored by Presage Biosciences.

COMPLETED
Registry status
Early Phase 1
Development phase
12 participants
Enrollment target
6
Study locations

Study Summary

This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of TAK-981 and TAK-981 combined with cetuximab or avelumab when administered intratumorally in microdose quantities via the CIVO device. CIVO stands for comparative in vivo oncology.

Conditions Studied

Head and Neck Cancer

Interventions

  • BIOLOGICAL Cetuximab
  • BIOLOGICAL Avelumab
  • DRUG TAK-981
  • COMBINATION_PRODUCT TAK-981 + Cetuximab
  • COMBINATION_PRODUCT TAK-981 + Avelumab

Study Locations (6)

New York

  • Northwell Health (Lenox Hill) - New York
  • Northwell Health (Monter Cancer Center) - North New Hyde Park

Oregon

  • Oregon Health & Science University (OHSU) - Portland
  • Portland VA - Portland

Michigan

  • University of Michigan - Ann Arbor

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2020-10-07
Est. Completion 2022-07-20
Phase Early Phase 1

Sponsor

Presage Biosciences

8 total trials

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What the Registry Record Tells You About NCT04065555

The ClinicalTrials.gov registry entry for NCT04065555 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Presage Biosciences, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cetuximab is the first listed.

NCT04065555 reports 6 study locations spanning 4 distinct geographic areas - top geographies include New York, Oregon, Michigan.

Frequently Asked Questions

What is clinical trial NCT04065555 about?

NCT04065555 is a clinical study titled "Intratumoral Microdosing of TAK-981 in Head and Neck Cancer". This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of TAK-981 and TAK-981 combined with cetuximab or avelumab when administered intratumorally in microdose quantitie...

What is the current status of trial NCT04065555?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2020-10-07. Estimated completion is 2022-07-20.

What conditions does trial NCT04065555 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

What interventions are being tested in trial NCT04065555?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Avelumab (BIOLOGICAL), TAK-981 (DRUG), TAK-981 + Cetuximab (COMBINATION_PRODUCT), TAK-981 + Avelumab (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04065555?

This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04065555 being conducted?

This trial has 6 study locations across Michigan, New York, Oregon, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.