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NCT03562637 · ClinicalTrials.gov registry record · Phase 3
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
A Phase 3 study of Triple Negative Breast Cancer, sponsored by OBI Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 575
- Enrollment target
- 20
- Study locations
NCT03562637: Active Phase 3 study of Triple Negative Breast Cancer, sponsored by OBI Pharma.
NCT03562637 is a Phase 3 study of Triple Negative Breast Cancer that is active but no longer recruiting, run by OBI Pharma. The registered enrollment target is 575 participants, above the 242-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03562637, a Phase 3 study of Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by OBI Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 575 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The outcome measure of the study is IDFS, defined by the STEEP system as the first occurrence of the time from the date of randomization to the date of first invasive disease recurrence (local, regional or distant), the date of secondary primary invasive cancer (breast or not), or the date of death from any cause.
Conditions Studied
Interventions
- OTHER Standard of care treatment
- BIOLOGICAL adagloxad simolenin combined with OBI-821
- DEVICE Globo H IHC Assay
Study Locations (20)
California
- Moores UCSD Cancer Center - La Jolla
- Kaiser Permanente Medical Center - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Centre - San Francisco
Other
- St Vincent's Hospital Sydney - Darlinghurst
- Gosford Hospital - Gosford
- St John of God Murdoch Hospital - Murdoch
Victoria
- Victoria Breast & Oncology Care - East Melbourne
- Cabrini Malvern - Malvern
Florida
- Miami Cancer Institute - Miami
Illinois
- University of Chicago Medical - Chicago
Maryland
- University of Maryland Greenbaum Comprehensive Cancer Center - Baltimore
Michigan
- Henry Ford Medical Center - Detroit
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 3 |
What the registry record for NCT03562637 still lists
NCT03562637 is an interventional study that assigns participants to a tested intervention. The registered 575 participants enrollment target is mid-sized for trials with a published cap, above the 242-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (138% higher).
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Standard of care treatment is the first listed.
NCT03562637 names 20 study sites across 15 states, led by California, Other, Victoria.
Frequently Asked Questions
What is clinical trial NCT03562637 about?
NCT03562637 is a clinical study titled "Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC". 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.
What is the current status of trial NCT03562637?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 575 participants. The study started on 2018-12-05. Estimated completion is 2027-12-30.
What conditions does trial NCT03562637 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT03562637?
The interventions under investigation include: Standard of care treatment (OTHER), adagloxad simolenin combined with OBI-821 (BIOLOGICAL), Globo H IHC Assay (DEVICE).
Who is sponsoring clinical trial NCT03562637?
This trial is sponsored by OBI Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03562637 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03562637's enrollment target sits among peer trials
575 14th of 118 higher than 105 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
RECRUITING · Phase 3
-
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
RECRUITING · Phase 3
-
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
ACTIVE NOT RECRUITING · Phase 3
-
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
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