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Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
NCT03562637 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03562637
The ClinicalTrials.gov registry entry for NCT03562637 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OBI Pharma, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03562637 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Other, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03562637?
This trial is sponsored by OBI Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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