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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: Completed Phase 1 study of HER2-positive Breast Cancer and Chordoma, sponsored by Bavarian Nordic.
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 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Frequency of patients with DLTs
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2024-12-11 |
| Phase | Phase 1 |
What the finished NCT04246671 record still lists
NCT04246671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (84% lower).
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 lists 9 locations in 8 states (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.
Learn More About Clinical Trials
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Where NCT04246671's enrollment target sits among peer trials
37 36th of 58 higher than 22 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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