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COMPLETED Phase 1

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

NCT04246671 · View on ClinicalTrials.gov ↗

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.

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

16 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. 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 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT04246671 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arizona, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04246671?

The interventions under investigation include: TAEK-VAC-HerBy (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04246671?

This trial is sponsored by Bavarian Nordic, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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