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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Biological: adagloxad simolenin combined with OBI-821; Device: Globo H IHC Assay; Other: Standard of care treatment

• Study Type: Interventional
• Enrollment (Actual): 575
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Darlinghurst, Australia, 2010
    • St Vincent's Hospital Sydney
  • Gosford, Australia, 2250
    • Gosford Hospital
  • Murdoch, Australia, 6150
    • St John of God Murdoch Hospital
  • Ringwood East, Australia, 3135
    • Eastern Health - Maroondah Hospital
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Urraween, Queensland, Australia, 4655
      • Cancer Care Service, Hervey Bay Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Victoria Breast & Oncology Care
    • Malvern, Victoria, Australia, 3144
      • Cabrini Malvern
  • Western Australia
    • Nedlands, Western Australia, Australia
      • Breast Cancer Research Centre
• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41253-90
      • Hospital Sao Rafael
  • Ceara
    • Fortaleza, Ceara, Brazil, 60810
      • Suporte Nutricional e Quimioterapia
  • Espirito Santo
    • Serra, Espirito Santo, Brazil, 29160-750
      • Centro de Avaliacao de Medicamentos e Especialidades de Pesquisa
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30380-472
      • Instituto Mario Penna
  • Para
    • Belém, Para, Brazil, 66073-005
      • Centro de Tratamento Oncologico LTDA - CTO
  • Parana
    • Campo Largo, Parana, Brazil, 83606-177
      • Maternidade e Cirurgia Nossa Senhora do Rocio
    • Curitiba, Parana, Brazil, 80060-900
      • Hospital das Clinicas - Universidade Federal do Parana
  • Pernambuco
    • Recife, Pernambuco, Brazil, 52010-000
      • Hospital do Capibaribe
    • Recife, Pernambuco, Brazil, 52010-075
      • Real Hospital Portugues de Beneficencia de Pernambuco
  • Piaui
    • Teresina, Piaui, Brazil, 64049-200
      • Centro de Pesquisa Vencer & Oncolinca
  • Rio Grande Do Sul
    • Barretos, Rio Grande Do Sul, Brazil
      • Hospital De Clinicas De Porto Alegre
    • Ijuí, Rio Grande Do Sul, Brazil, 98700
      • Oncosite-Centro de Pesquisa Clinica em Oncologia
    • Pelotas, Rio Grande Do Sul, Brazil, 96040-010
      • Hospital Escola da Universidade Federal de Pelotas
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericordia de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas
  • Rondona
    • Porto Velho, Rondona, Brazil, 76834-899
      • Hospital de Amor Amazônia
  • Roraima
    • Boa Vista, Roraima, Brazil, 69304-015
      • Centro Oncológico de Roraima
  • Santa Catarina
    • Chapeco, Santa Catarina, Brazil, 89801-355
      • Clínica Supera
    • Itajaí, Santa Catarina, Brazil, 88300-000
      • Clinica de Neoplasias Litoral - Itajai
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784
      • Hospital de Cancer de Barretos
    • Jaú, Sao Paulo, Brazil, 17210-120
      • Hospital Amaral Carvalho de Jau
    • Santo André, Sao Paulo, Brazil, 09060
      • Centro de Pesquisa Clinica em Hematologia e Oncologia
    • São Paulo, Sao Paulo, Brazil, 01317-001
      • Clinicia de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria
    • São Paulo, Sao Paulo, Brazil, 04014
      • Instituto Brasileiro de Controle Do Cancer
    • São Paulo, Sao Paulo, Brazil, 05403-900
      • Instituto do Cancer do Estado de San Paulo
• China
  • Beijing, China, 100024
    • Cancer Institute and Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin medical university cancer hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210036
      • Jiangsu Province Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Liaoning Cancer Hospital and Institute
    • Shenyang, Liaoning, China, 110101
      • The First Hospital of China Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin cancer hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital
• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Queen Mary Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Goyang-si, Korea, Republic of, 10408
    • National Cancer Center
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
  • Suwon-si, Korea, Republic of, 16247
    • The Catholic university of Korea, St. Vincent's Hospital
• Mexico
  • Aguascalientes, Mexico, 20010
    • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de. C.V
  • Chihuahua, Mexico, 31000
    • Centro Estatal de Cancerologia
  • Chihuahua, Mexico, 31000
    • Icaro Investigaciones en Medicina S.A. de C.V.
  • Chihuahua, Mexico, 31207
    • Scientia Investigacion Clinica S.C.
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25279
      • Clinica Oncor - Centro de Infusion e Investigacion Oncologia de Satillo
  • Del Tialpan
    • Ciudad de mexico, Del Tialpan, Mexico, 14080
      • Instituto Nacional de Cancerologia
  • Estado De Mexico
    • Toluca, Estado De Mexico, Mexico, 50180
      • Centro Oncologico Estatal Instituto de Seguridad Social del Estado de Mexico y Municipios
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45070
      • Investigación Biomédica para el Desarrollo de Fármacos
  • Michoacan
    • Morelia, Michoacan, Mexico, 58260
      • Sociedad Administradora de Servicios de Salud S.C.
  • Nuevo Leon
    • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
      • Centro Medico Zambrano Hellion
• Peru
  • Arequipa, Peru, 04002
    • Instituto Regional de Enfermedades Neoplásicas del Sur
  • Lima, Peru, 15072
    • Hospital Nacional Edgardo Rebagliati Martins, Unidad de Investigacion de Oncologia Medica
  • Lima, Peru, 15072
    • Unidad de Investigacion - Oncologia Medica Clinica San Felipe
  • Lima, Peru, 15801
    • Hospital Maria Auxiliadora
  • Surquillo
    • Lima, Surquillo, Peru, 15038
      • Instituto Nacional de Enfermedades Neoplasicas
• Poland
  • Gdańsk, Poland, 80-214
    • University Clinical Centre - Hospital, Teaching Dept of Oncology and Radiotherapy
  • Kraków, Poland, 30-688
    • Independent Public Healthcare Facility University Hospital in Cracow
  • Warsaw, Poland, 02-507
    • Central Teaching Hospital of the MOI in Warsaw
  • Warsaw, Poland, 02-781
    • Maria Sklodowska-Curie National Institute of Oncology
  • Łódź, Poland, 90-242
    • Contemporary Therapy Centre
  • Łódź, Poland, 93-338
    • Polish Mother's Memorial Hospital Research Instistute
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
  • Krasnoyarsk, Russian Federation, 660133
    • Krasnoyarsk Territorial Clinical Oncology Center named after A.I. Kryzhanovsky
  • Moscow, Russian Federation, 115478
    • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  • Moscow, Russian Federation, 143423
    • SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare department
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region "Clinical Oncology Dispensary"
  • Orenburg, Russian Federation, 460021
    • Orenburg Regional Clinical Oncological Center
  • Pesochnyy, Russian Federation, 197758
    • N.N. Petrov National Medical Research Center of Oncology
  • Saint Petersburg, Russian Federation, 194356
    • LLC Medaid
  • Saint-Petersburg, Russian Federation, 197022
    • SPb SBIH "City Clinical Oncological Dispensary"
  • St. Petersburg, Russian Federation, 197110
    • Klinika Luch, Ltd.
  • Volzhskiy, Russian Federation, 404133
    • SBHI "Volgograd Regional Oncology Dispensary #3"
  • Yaroslavl, Russian Federation, 150054
    • SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
  • Republic Of Mordovia
    • Saransk, Republic Of Mordovia, Russian Federation, 430005
      • Nat. Research Mordovia State University
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • Medical Oncology Centre of Rosebank
    • Johannesburg, Gauteng, South Africa, 2193
      • Netcare Milpark Hospital
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research, a division of Wits Health Consortium (Pty) Ltd
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 11259
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei, Taiwan, 10507
    • Chang Gung Medical Foundation Linkou
• Ukraine
  • Dnipro, Ukraine, 49044
    • Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
  • Dnipro, Ukraine, 49102
    • City Clinical Hospital #4
  • Ivano-Frankivsk, Ukraine, 76018
    • CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU
  • Kharkiv, Ukraine, 61166
    • CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
  • Kherson, Ukraine, 73000
    • CI of Kherson Reg Council Kherson Regional Oncologic Dispensary
  • Kyiv, Ukraine, 03115
    • Kyiv Сity Clinical Oncological Center
  • Kyiv, Ukraine, 03002
    • Medical Center of Vision Partner
  • Kyiv, Ukraine, 03039
    • Medical Center Verum
  • Zhytomyr, Ukraine, 10002
    • CI Reg. Oncol. Dispanser
• United States
  • California
    • La Jolla, California, United States, 92093
      • Moores UCSD Cancer Center
    • San Diego, California, United States, 92120
      • Kaiser Permanente Medical Center
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Family Comprehensive Cancer Centre
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenbaum Comprehensive Cancer Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Bons Secours St. Francis Medical Oncology Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • NorthWest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
  • Definitive surgery followed by adjuvant chemotherapy: Pathological Prognostic Stage IIB, Stage IIIA , Stage IIIB, or Stage IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual.

• Must have completed at least 4 cycles of a standard taxane and anthracycline-based multi-agent chemotherapy regimen (or a taxane-only regimen if the patient is ineligible for anthracycline treatment) either in the neoadjuvant or adjuvant setting (e.g., National Comprehensive Cancer Network recommended regimens):.

  • Randomization must occur (a) within 16 weeks after definitive surgery and radiation therapy (if radiation therapy administered) in patients who received neoadjuvant multiagent chemotherapy or, (b) for patients receiving adjuvant multiagent chemotherapy (not including capecitabine, immune checkpoint inhibitor), within 16 weeks after the completion of the adjuvant multiagent chemotherapy and radiation therapy (if radiation therapy administered). Note: patients may be randomized and initiate study treatment concurrent with adjuvant SOC therapy (observation, capecitabine, immune checkpoint inhibitor ± capecitabine).
• Randomization must occur (a) within 16 weeks after definitive surgery and radiation therapy (if radiation therapy administered) in patients who received neoadjuvant multiagent chemotherapy or, (b) for patients receiving adjuvant multiagent chemotherapy (not including capecitabine, immune checkpoint inhibitor), within 16 weeks after the completion of the adjuvant multiagent chemotherapy and radiation therapy (if radiation therapy administered). Note: patients may be randomized and initiate study treatment concurrent with adjuvant SOC therapy (observation, capecitabine, immune checkpoint inhibitor ± capecitabine).
• All treatment-related toxicities resolved to Grade <1 on National cancer institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0) criteria (except hair loss and ≤Grade 2 neuropathy, which are acceptable).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Females must be either of non-childbearing potential, i.e., surgically sterilized (have documented sterilization, bilateral oophorectomy/salpingectomy at least 3 months before the start of the trial and/or hysterectomy), or one year postmenopausal; or if of childbearing potential must have a negative pregnancy test (urine or serum) at screening.
• Males and females of childbearing potential and their partners must be willing to use effective contraception during the entire Treatment Phase and for at least 4 weeks (28 days) after the last dose of study treatment.

• Adequate hematological, hepatic and renal function as defined below:

  • Absolute neutrophil count (ANC) ≥1,500/µL
  • Platelets ≥75,000/µL
  • Hemoglobin ≥8.5g/dL
  • Serum creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥55 mL/min for subjects with creatinine levels >1.5 × institutional ULN (glomerular filtration rate can also be used in place of creatinine or creatinine clearance may be calculated per institutional standard)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN
  • Alkaline Phosphatase (ALP) ≤2.5 × ULN
  • Serum total bilirubin ≤1.5 × ULN (unless Gilbert's disease is documented)
• Consent to participate with a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient informed consent for the study prior to beginning any specific study procedures.
• Ability to understand and willingness to complete all protocol required procedures.

Exclusion Criteria:

• Local recurrence of or previous history of ipsilateral or contralateral invasive breast cancer within 10 years prior to randomization [for synchronous tumors see Exclusion criteria #3]
• 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.
• Known history or positive for human immunodeficiency virus (HIV positive), unless on effective anti-retroviral therapy with undetectable viral load within 6 months of therapy (note: HIV testing not required for study entry).
• Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to randomization. Patients who have completed curative therapy and have undetectable viral load for HCV are eligible. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy. (note: HBV/HCV testing is not required for study entry).
• Any condition, including significant diseases and/or laboratory abnormalities that would place the patient at unacceptable risk for study participation.
• Currently pregnant or breastfeeding women.
• Currently participating in or has participated in a breast cancer therapeutic clinical trial within 4 weeks (28 days) prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adagloxad simolenin + OBI-821 in conjunction with SOC; Participants will be administered adagloxad simolenin combined with OBI-821 for up to a total of 21 subcutaneous injections over a period of 100 weeks. Patient will also receive standard of care (SOC) treatment.	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.
Active Comparator: Standard of Care treatment; Study visit intervals will be identical to those in Arm 1. Patient will receive standard of care (SOC) treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improving invasive disease free survival (IDFS) in the study population.	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Overall Survival (OS).	OS is defined as the time from randomization to date of death from any cause	7 years
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Quality of Life (QoL).	QoL defined as time to definitive deterioration in Health-related Quality of Life (HRQOL) using the global health status/QoL scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L). QoL baseline established at randomization. Definitive deterioration defined as a 5% worsening relative to baseline in the HRQOL scale score from EORTC QLQ-C30 questionnaires with no subsequent improvement above threshold, scored with the EORTC QLQ-C30 v3.0 Scoring Manual. The EQ-5D-5L questionnaire assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, rated by the patient. It is a standardized measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. 28 questions have a 4 point scale: not at all(1) to very much(4). 2 questions have a 7-point scale: very poor (1) to excellent(7).	7 years
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Breast cancer-free interval (BCFI).	BCFI is defined by the STEEP system as the first occurrence of the time from the date of randomization to the date of the first invasive disease recurrence (local, regional or distant), the date of ductal carcinoma in situ (ipsilateral or contralateral), or the date of death from breast cancer	7 years
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Distant disease-free survival (DDFS).	DDFS is defined by the STEEP system as the first occurrence of the time from the date of randomization to the date of the first distant disease recurrence, the date of the second primary invasive cancer (non-breast), or the date of death from any cause	7 years
Incidence and severity of adverse events (AEs) [Time Frame: AEs will be noted as it occurs, with a timeframe from beginning of randomization to 4 weeks after last dose of study treatment.]	Adverse Events will be graded and recorded by investigators per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).	2 years

Collaborators and Investigators

• Sponsor: OBI Pharma, Inc
• Investigators: Study Chair: Hope Rugo, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Rugo HS, Cortes J, Barrios CH, Cabrera P, Xu B, Huang CS, Kim SB, Melisko M, Nanda R, Pienkowski T, Rapoport BL, Schwab R. GLORIA: phase III, open-label study of adagloxad simolenin/OBI-821 in patients with high-risk triple-negative breast cancer. Future Oncol. 2022 Oct 21. doi: 10.2217/fon-2022-0812. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Adjuvant chemotherapy; TNBC; Neoadjuvant chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: OBI-822-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes