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NCT04246671 · ClinicalTrials.gov registry record · Phase 1

TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer

A Phase 1 study of HER2-positive Breast Cancer and Chordoma, sponsored by Bavarian Nordic.

Completed
Registry status
Phase 1
Development phase
37
Enrollment target
9
Study locations

NCT04246671 is a Phase 1 study of HER2-positive Breast Cancer and Chordoma that has completed, run by Bavarian Nordic. The registered enrollment target is 37 participants, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT04246671, a Phase 1 study of HER2-positive Breast Cancer and Chordoma, has completed, sponsored by Bavarian Nordic.

COMPLETED
Registry status
Phase 1
Development phase
37 participants
Enrollment target
9
Study locations

Study Summary

A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer. The study will be completed in 2 stages. In Stage 1 patients will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 4 dose levels will be explored to determine the recommended dose of TAEK-VAC-HerBy for Stage 2 of the trial. Stage 2 will enroll either chordoma patients for treatment with TAEK-VAC-HerBy alone, or HER2- positive breast cancer patients for combination treatment of TAEK-VAC-HerBy vaccine and therapeutic HER2 antibodies (trastuzumab). Patients in both stages will receive TAEK-VAC-HerBy intravenously, every three weeks, three administrations in total.

Conditions Studied

HER2-positive Breast Cancer Chordoma

Interventions

  • BIOLOGICAL TAEK-VAC-HerBy

Study Locations (9)

Florida

  • Mayo Clinic - Jacksonville - Jacksonville
  • H. Lee Moffitt Cancer Center - Tampa

Arizona

  • Mayo Clinic - Phoenix - Scottsdale

California

  • Providence Saint John's Health Center - Santa Monica

Georgia

  • Georgia Cancer Center Augusta University - Augusta

Massachusetts

  • Massachusetts General Hospital - Boston

Minnesota

  • Mayo Clinic - Rochester - Rochester

Oregon

  • Providence Cancer Institute - Portland

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2020-08-10
Est. Completion 2024-12-11
Phase Phase 1

Sponsor

Bavarian Nordic

41 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04246671

The ClinicalTrials.gov registry entry for NCT04246671 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (85% lower). The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which TAEK-VAC-HerBy is the first listed.

NCT04246671 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Florida, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT04246671 about?

NCT04246671 is a clinical study titled "TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer". A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer. The study will be completed in 2 stages. In Stage 1 patients will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 4 dose lev...

What is the current status of trial NCT04246671?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-08-10. Estimated completion is 2024-12-11.

What conditions does trial NCT04246671 study?

This clinical trial studies the following conditions: HER2-positive Breast Cancer, Chordoma.

What interventions are being tested in trial NCT04246671?

The interventions under investigation include: TAEK-VAC-HerBy (BIOLOGICAL).

Who is sponsoring clinical trial NCT04246671?

This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04246671 being conducted?

This trial has 9 study locations across Arizona, California, Florida, Georgia, Massachusetts. 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.