drugset / Trial / NCT04674306
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer
Phase 0
Completed
35 enrolled
George T. Budd
Anixa Biosciences, Inc. · collabUnited States Department of Defense · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer, participants who are of cancer-free but may be at risk for triple-negative breast cancer, and for participants who are receiving adjuvant pembrolizumab following initial triple negative breast cancer treatment.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2025-12-15
- Completion
- 2025-12-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zymosan | Unknown | 10 ug | — |
| Subject | Zymosan | Unknown | 20 ug | — |
| Subject | Zymosan | Unknown | 100 ug | — |
| Subject | α-lactalbumin | Vaccine | 10 ug | Subcutaneous |
| Subject | α-lactalbumin | Vaccine | 20 ug | Subcutaneous |
| Subject | α-lactalbumin | Vaccine | 50 ug | Subcutaneous |
| Subject | α-lactalbumin | Vaccine | 100 ug | Subcutaneous |
| Subject | α-lactalbumin | Vaccine | 500 ug | Subcutaneous |