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

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT03562637•OBI Pharma, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented radiographic and histopathologic confirmed primary localized invasive breast cancer.
•Histologically documented TNBC (estrogen receptor negative \[ER-\]/progesterone receptor negative \[PR-\]/human epidermal growth factor 2 negative \[HER2-\]) defined as ER-negative and PR-negative (≤5% positive cells stain by IHC for both ER and PR), and negative HER2/neu- status, confirmed on tumor sample.
•HER2/neu negative will be defined as one of the following criteria:
•* IHC 0 or 1+
•* Single-probe average HER2 gene copy number of \<6 signals/nucleus
•* Dual-probe fluorescent in-situ hybridization (FISH) HER2/neu chromosome 17 (CEP17) non-amplified ratio of \<2
•Globo H IHC H-score ≥15 from the residual primary site/or lymph node (if primary site is not available) tumor obtained at time of definitive surgery or initial diagnosis (only if surgical tumor sample is not available). Globo H expression will be determined during pre-screening by Central lab. Instructions for submission of slides/tumor tissue blocks are provided in the protocol and study Lab Manual.
•No evidence of metastatic disease in chest, abdomen and pelvis by CT or other adequate imagining during the Screening Phase. Imaging within 3 months prior to randomization is acceptable as baseline scan. Bone scans and imaging of the brain at screening is optional, and should be symptom directed.
•High risk patients with no evidence of disease after completing standard treatment and meeting ONE of the following criteria:
•* Neoadjuvant chemotherapy followed by definitive surgery: Residual invasive disease following neoadjuvant chemotherapy defined as: A contiguous focus of residual invasive cancer in the surgical breast specimen measuring ≥1 cm in diameter and/or with residual invasive cancer in at least one axillary node (micrometastases or macrometastases), as determined by local pathology review.
+18 more criteria

Exclusion Criteria

•Definitive clinical or radiologic evidence of metastatic disease
•Synchronous bilateral breast cancer, unless both tumors are confirmed as TNBC.
•Have received any anti-cancer vaccines
•Concomitant treatment with anticancer therapy other than adjuvant SOC therapy (capecitabine; immune checkpoint inhibitor), or other investigational therapy, if expected during the study
•A history of other malignancies (except appropriately treated melanoma in situ, non melanoma skin carcinoma, carcinoma in situ of the uterine cervix, follicular or papillary thyroid cancer or other non-breast malignancies with a similar outcome to those mentioned above) within 5 years prior to randomization.
•Have any active autoimmune disease or disorder that requires systemic immunosuppressive/immunomodulatory therapy. NOTE: Autoimmune diseases that are confined to the skin (e.g., psoriasis) that can be treated with topical steroids alone are allowed during the study.
•Oral/parenteral corticosteroid treatment (\>5 mg/day of prednisone/equivalent), within 2 weeks prior to randomization or anytime during the study. NOTE: inhaled steroids for treatment of asthma; and topical steroids are allowed during the study.
•Any known uncontrolled concurrent illness that would limit compliance with study requirements, including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorders, or substance abuse.
•Any known hypersensitivity to active/inactive ingredients in the study drug formulation or known severe allergy or anaphylaxis to fusion proteins.
•Prior receipt of a glycoconjugate vaccine for cancer immunotherapy.
+5 more criteria

Locations (128)

Moores UCSD Cancer Center

La Jolla, California, United States

Kaiser Permanente Medical Center

San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Centre

San Francisco, California, United States

Miami Cancer Institute

Miami, Florida, United States

University of Chicago Medical

Chicago, Illinois, United States

University of Maryland Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Henry Ford Medical Center

Detroit, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

December 5, 2018

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2027

Last Updated

May 9, 2025

Enrollment

575

ACTUAL participants

Conditions

Triple Negative Breast Cancer

Interventions

adagloxad simolenin combined with OBI-821

BIOLOGICAL

Globo H IHC Assay

DEVICE

Standard of care treatment

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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