NCT03562637

Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High Risk, Early Stage Globo H-Positive Triple Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 575 (actual)
• Sponsor: OBI Pharma, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	adagloxad simolenin combined with OBI-821	In the neoadjuvant and adjuvant phases of the study for a total of 100 weeks; subcutaneously injections.
DEVICE	Globo H IHC Assay	The Globo H IHC assay will be used to identify eligible patients who may clinically benefit from the OBI-822 treatment, defined by Globo H expression.
OTHER	Standard of care treatment	Standard of care treatment consisting of observation alone, adjuvant capecitabine or platinum monotherapy over a 100 week period.

Timeline

• Start date: 2018-12-05
• Primary completion: 2025-12-30
• Completion: 2027-12-30
• First posted: 2018-06-19
• Last updated: 2025-05-09

Locations

128 sites across 13 countries: United States, Australia, Brazil, China, Hong Kong, Mexico, Peru, Poland, Russia, South Africa, South Korea, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study
• FDA-regulated device study