drugset / Trial / NCT03562637
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
RandomizedParallel-groupOpen-labelTreatment
Summary
The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.
Timeline
- Start
- 2018-12-05
- Primary completion
- 2025-12-30
- Completion
- 2027-12-30
Publications
- Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.
- Rugo HS, Cortes J, Barrios CH, Cabrera P, Xu B, Huang CS, Kim SB, Melisko M, Nanda R, Pienkowski T, Rapoport BL, Schwab R. GLORIA: phase III, open-label study of adagloxad simolenin/OBI-821 in patients with high-risk triple-negative breast cancer. Future Oncol. 2022 Oct 21. doi: 10.2217/fon-2022-0812. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OBI-821 | Other / unclassified | — | Subcutaneous |
| Subject | adagloxad simolenin | Vaccine | — | Subcutaneous |