AzTrials
AzTrials

Triple Negative Breast CancerPhase 3NCT03562637

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

A Phase 3 study testing adagloxad simolenin combined with OBI-821 and Globo H IHC Assay in people with Triple Negative Breast Cancer, run by OBI Pharma, Inc at 128 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
adagloxad simolenin combined with OBI-821 and Globo H IHC Assay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
575 participants
Where
128 sitesin 13 countries
Study dates
5 Dec 2018to 30 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

128 sites in 13 countries.

128 sites in 13 countries

Brazil25 sites

  • Hospital de Clinicas de Porto Alegre

    Barretos, Rio Grande do Sul

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784

  • Centro de Tratamento Oncologico LTDA - CTO

    Belém, Pará, 66073-005

  • Instituto Mario Penna

    Belo Horizonte, Minas Gerais, 30380-472

  • Centro Oncologico de Roraima

    Boa Vista, Roraima, 69304-015

  • Maternidade e Cirurgia Nossa Senhora do Rocio

    Campo Largo, Paraná, 83606-177

  • Clinica Supera

    Chapecó, Santa Catarina, 89801-355

  • Hospital das Clinicas - Universidade Federal do Parana

    Curitiba, Paraná, 80060-900

  • Suporte Nutricional e Quimioterapia

    Fortaleza, Ceará, 60810

  • Oncosite-Centro de Pesquisa Clinica em Oncologia

    Ijuí, Rio Grande do Sul, 98700

  • Clinica de Neoplasias Litoral - Itajai

    Itajaí, Santa Catarina, 88300-000

  • Hospital Amaral Carvalho de Jau

    Jaú, São Paulo, 17210-120

  • Hospital Escola da Universidade Federal de Pelotas

    Pelotas, Rio Grande do Sul, 96040-010

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital de Amor Amazonia

    Porto Velho, Rondona, 76834-899

  • Hospital do Capibaribe

    Recife, Pernambuco, 52010-000

  • Real Hospital Portugues de Beneficencia de Pernambuco

    Recife, Pernambuco, 52010-075

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 41253-90

  • Centro de Pesquisa Clinica em Hematologia e Oncologia

    Santo André, São Paulo, 09060

  • Clinicia de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria

    São Paulo, São Paulo, 01317-001

  • Instituto Brasileiro de Controle do Cancer

    São Paulo, São Paulo, 04014

  • Instituto do Cancer do Estado de San Paulo

    São Paulo, São Paulo, 05403-900

  • Centro de Avaliacao de Medicamentos e Especialidades de Pesquisa

    Serra, Espírito Santo, 29160-750

  • Centro de Pesquisa Vencer & Oncolinca

    Teresina, Piauí, 64049-200

Other trials in Brazil

China17 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Cancer Institute and Hospital

    Beijing, 100024

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310020

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210036

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110001

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110101

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

Other trials in China

Russia13 sites

  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

    Arkhangelsk, 163045

  • Krasnoyarsk Territorial Clinical Oncology Center named after A.I. Kryzhanovsky

    Krasnoyarsk, 660133

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, 115478

  • SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare department

    Moscow, 143423

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, 644013

  • Orenburg Regional Clinical Oncological Center

    Orenburg, 460021

  • N.N. Petrov National Medical Research Center of Oncology

    Pesochnyy, 197758

  • LLC Medaid

    Saint Petersburg, 194356

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

  • Klinika Luch, Ltd.

    Saint Petersburg, 197110

  • Nat. Research Mordovia State University

    Saransk, Respublika Mordoviya, 430005

  • SBHI "Volgograd Regional Oncology Dispensary #3"

    Volzhskiy, 404133

  • SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

    Yaroslavl, 150054

Other trials in Russia

United States12 sites

  • University of Maryland Greenbaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • University of Chicago Medical

    Chicago, Illinois, 60637

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Bons Secours St. Francis Medical Oncology Center

    Midlothian, Virginia, 23114

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Kaiser Permanente Medical Center

    San Diego, California, 92120

  • UCSF Helen Diller Family Comprehensive Cancer Centre

    San Francisco, California, 94158

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

Other trials in United States

Mexico10 sites

  • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de. C.V

    Aguascalientes, 20010

  • Centro Estatal de Cancerologia

    Chihuahua City, 31000

  • Icaro Investigaciones en Medicina S.A. de C.V.

    Chihuahua City, 31000

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207

  • Instituto Nacional de Cancerologia

    Mexico City, Del Tialpan, 14080

  • Sociedad Administradora de Servicios de Salud S.C.

    Morelia, Michoacán, 58260

  • Clinica Oncor - Centro de Infusion e Investigacion Oncologia de Satillo

    Saltillo, Coahuila, 25279

  • Centro Medico Zambrano Hellion

    San Pedro Garza García, Nuevo León, 66278

  • Centro Oncologico Estatal Instituto de Seguridad Social del Estado de Mexico y Municipios

    Toluca, State of Mexico, 50180

  • Investigacion Biomedica para el Desarrollo de Farmacos

    Zapopan, Jalisco, 45070

Other trials in Mexico

Australia9 sites

  • St Vincent's Hospital Sydney

    Darlinghurst, 2010

  • Victoria Breast & Oncology Care

    East Melbourne, Victoria, 3002

  • Gosford Hospital

    Gosford, 2250

  • Cabrini Malvern

    Malvern, Victoria, 3144

  • St John of God Murdoch Hospital

    Murdoch, 6150

  • Breast Cancer Research Centre

    Nedlands, Western Australia

  • Eastern Health - Maroondah Hospital

    Ringwood East, 3135

  • Cancer Care Service, Hervey Bay Hospital

    Urraween, Queensland, 4655

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

South Korea9 sites

  • Dong-A University Hospital

    Busan, 49201

  • National Cancer Center

    Goyang-si, 10408

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Medical Foundation Linkou

    Taipei, 10507

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11259

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

Ukraine9 sites

  • Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

    Dnipro, 49044

  • City Clinical Hospital #4

    Dnipro, 49102

  • CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU

    Ivano-Frankivsk, 76018

  • CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

    Kharkiv, 61166

  • CI of Kherson Reg Council Kherson Regional Oncologic Dispensary

    Kherson, 73000

  • Medical Center of Vision Partner

    Kyiv, 03002

  • Medical Center Verum

    Kyiv, 03039

  • Kyiv Сity Clinical Oncological Center

    Kyiv, 03115

  • CI Reg. Oncol. Dispanser

    Zhytomyr, 10002

Other trials in Ukraine

Poland6 sites

  • University Clinical Centre - Hospital, Teaching Dept of Oncology and Radiotherapy

    Gdansk, 80-214

  • Independent Public Healthcare Facility University Hospital in Cracow

    Krakow, 30-688

  • Contemporary Therapy Centre

    Lodz, 90-242

  • Polish Mother's Memorial Hospital Research Instistute

    Lodz, 93-338

  • Central Teaching Hospital of the MOI in Warsaw

    Warsaw, 02-507

  • Maria Sklodowska-Curie National Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Peru5 sites

  • Instituto Regional de Enfermedades Neoplasicas del Sur

    Arequipa, 04002

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Surquillo, 15038

  • Hospital Nacional Edgardo Rebagliati Martins, Unidad de Investigacion de Oncologia Medica

    Lima, 15072

  • Unidad de Investigacion - Oncologia Medica Clinica San Felipe

    Lima, 15072

  • Hospital Maria Auxiliadora

    Lima, 15801

Other trials in Peru

South Africa3 sites

  • Netcare Milpark Hospital

    Johannesburg, Gauteng, 2193

  • Wits Clinical Research, a division of Wits Health Consortium (Pty) Ltd

    Johannesburg, Gauteng, 2193

  • Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

Other trials in South Africa

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong, 00000

Other trials in Hong Kong

About this study

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

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.

Being tested
adagloxad simolenin combined with OBI-821, Globo H IHC Assay, Standard of care treatment
Keywords
Neoadjuvant chemotherapy, Adjuvant chemotherapy, TNBC
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adagloxad simolenin combined with OBI-821Biological

    In the neoadjuvant and adjuvant phases of the study for a total of 100 weeks; subcutaneously injections.

  • Globo H IHC AssayDevice

    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.

  • Standard of care treatmentOther

    Standard of care treatment consisting of observation alone, adjuvant capecitabine or platinum monotherapy over a 100 week period.

Study groups in NCT03562637
Study groupRoleWhat they receive
Adagloxad simolenin + OBI-821 in conjunction with SOCExperimentalParticipants 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.
Receives: Biological: adagloxad simolenin combined with OBI-821; Device: Globo H IHC Assay; Other: Standard of care treatment
Standard of Care treatmentActive comparatorStudy visit intervals will be identical to those in Arm 1. Patient will receive standard of care (SOC) treatment.
Receives: Device: Globo H IHC Assay; Other: Standard of care treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

Secondary outcomes (5)

  1. 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

    Measured: 7 years

  2. 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).

    Measured: 7 years

  3. 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

    Measured: 7 years

  4. 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

    Measured: 7 years

  5. 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).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start5 Dec 2018
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
575 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562637
Sponsor's protocol ID
OBI-822-011
Status last verified
May 2025
First submitted
6 Jun 2018
Last updated
9 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

    PubMed 40443562

  • 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.

    PubMed 36268941

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adagloxad simolenin combined with OBI-821 and Globo H IHC Assay in people with Triple Negative Breast Cancer, run by OBI Pharma, Inc at 128 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in Brazil, China, Russia, United States, Mexico and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improving invasive disease free survival (IDFS) in the study population. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562637, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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