Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Hope Rugo, MD (ucsf)

Description

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.

Official Title

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

Keywords

Triple Negative Breast Cancer, Neoadjuvant chemotherapy, Adjuvant chemotherapy, TNBC, Breast Neoplasms, Triple Negative Breast Neoplasms, adagloxad simolenin combined with OBI-821, Globo H IHC Assay

Eligibility

Locations

  • Moores UCSD Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCSF Helen Diller Family Comprehensive Cancer Centre accepting new patients
    San Francisco California 94158 United States
  • Kaiser Permanente Medical Center accepting new patients
    San Diego California 92120 United States

Lead Scientist at University of California Health

  • Hope Rugo, MD (ucsf)
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
OBI Pharma, Inc
ID
NCT03562637
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 668 study participants
Last Updated