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NCT04246671
TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer
Phase 1 trial testing TAEK-VAC-HerBy in Chordoma in 37 participants. Completed in 11 December 2024.
17 February 2024
Quick facts
| Lead sponsor | Bavarian Nordic |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 10 August 2020 |
| Primary completion | 17 February 2024 |
| Estimated completion | 11 December 2024 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- TAEK-VAC-HerBy — full drug profile →
Conditions studied
- Chordoma — all drugs for Chordoma →
- HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
Sponsor
Bavarian Nordic — full company profile →
Who can join
18 and older, any sex, with Chordoma or HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04246671
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Bavarian Nordic trials
Trials by the same sponsor.
- NCT07199569 — Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells · Phase 2 · active not recruiting
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- NCT05329220 — ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 · Phase 3 · completed
- NCT05349617 — Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years · Phase 3 · completed
- NCT05238025 — MVA-BN-RSV Vaccine Trial · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04246671 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bavarian Nordic
- Last refreshed: 3 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04246671.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing