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

NCT03562637 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2025-05-09

No results posted yet for this 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

Interventions

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.

Sponsors & Collaborators

  • OBI Pharma, Inc

    lead INDUSTRY

Principal Investigators

  • Hope Rugo, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2025-12-30
Completion
2027-12-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Brazil
  • China
  • Hong Kong
  • Mexico
  • Peru
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03562637 on ClinicalTrials.gov