Clinical Trial

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

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated May 9, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 34 amendments
This ClinicalTrials.gov record has been amended 34 times since 2018-06-08; most recent amendment 2026-06-04.
Status change: Active, Not Recruiting → Terminated 2026-06-04
Status change: Recruiting → Active, Not Recruiting 2025-05-06
Status change: Not Yet Recruiting → Recruiting 2018-12-10
Trial Details
NCT Number NCT03562637
Lead Sponsor OBI Pharma, Inc
Conditions Triple Negative Breast Cancer
Enrollment 575 participants
Start Date 2018-12-05
Primary Completion 2025-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-09