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

NCT03562637 | Active Not Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: OBI-822-011
• Study Type: interventional
• Target: 575
• Locations: 13 countries
• Sites: 128

Brief 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

Triple Negative Breast Cancer

Keywords

Neoadjuvant chemotherapy; Adjuvant chemotherapy; TNBC

Outcome Measures

Primary Outcomes (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.

  5 years

Secondary Outcomes (5)

• Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Overall Survival (OS).

  7 years

• Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Quality of Life (QoL).

  7 years

• Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Breast cancer-free interval (BCFI).

  7 years

• Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Distant disease-free survival (DDFS).

  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.]

  2 years

Study Arms (2)

Adagloxad simolenin + OBI-821 in conjunction with SOC

EXPERIMENTAL

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; Device: Globo H IHC Assay; Other: Standard of care treatment

Standard of Care treatment

ACTIVE COMPARATOR

Study visit intervals will be identical to those in Arm 1. Patient will receive standard of care (SOC) treatment.

Device: Globo H IHC Assay; Other: Standard of care treatment

Interventions

adagloxad simolenin combined with OBI-821 BIOLOGICAL

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

Adagloxad simolenin + OBI-821 in conjunction with SOC

Globo H IHC Assay DEVICE

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.

Adagloxad simolenin + OBI-821 in conjunction with SOC; Standard of Care treatment

Standard of care treatment OTHER

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

Adagloxad simolenin + OBI-821 in conjunction with SOC; Standard of Care treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• OBI Pharma, Inc: lead

Study Sites (128)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Kaiser Permanente Medical Center

San Diego, California, 92120, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Centre

San Francisco, California, 94158, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

University of Chicago Medical

Chicago, Illinois, 60637, United States

Location

University of Maryland Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Bons Secours St. Francis Medical Oncology Center

Midlothian, Virginia, 23114, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Cancer Care Service, Hervey Bay Hospital

Urraween, Queensland, 4655, Australia

Location

Victoria Breast & Oncology Care

East Melbourne, Victoria, 3002, Australia

Location

Cabrini Malvern

Malvern, Victoria, 3144, Australia

Location

Breast Cancer Research Centre

Nedlands, Western Australia, Australia

Location

St Vincent's Hospital Sydney

Darlinghurst, 2010, Australia

Location

Gosford Hospital

Gosford, 2250, Australia

Location

St John of God Murdoch Hospital

Murdoch, 6150, Australia

Location

Eastern Health - Maroondah Hospital

Ringwood East, 3135, Australia

Location

Suporte Nutricional e Quimioterapia

Fortaleza, Ceará, 60810, Brazil

Location

Centro de Avaliacao de Medicamentos e Especialidades de Pesquisa

Serra, Espírito Santo, 29160-750, Brazil

Location

Hospital Sao Rafael

Salvador, Estado de Bahia, 41253-90, Brazil

Location

Instituto Mario Penna

Belo Horizonte, Minas Gerais, 30380-472, Brazil

Location

Maternidade e Cirurgia Nossa Senhora do Rocio

Campo Largo, Paraná, 83606-177, Brazil

Location

Hospital das Clinicas - Universidade Federal do Parana

Curitiba, Paraná, 80060-900, Brazil

Location

Centro de Tratamento Oncologico LTDA - CTO

Belém, Pará, 66073-005, Brazil

Location

Hospital do Capibaribe

Recife, Pernambuco, 52010-000, Brazil

Location

Real Hospital Portugues de Beneficencia de Pernambuco

Recife, Pernambuco, 52010-075, Brazil

Location

Centro de Pesquisa Vencer & Oncolinca

Teresina, Piauí, 64049-200, Brazil

Location

Hospital de Clinicas de Porto Alegre

Barretos, Rio Grande do Sul, Brazil

Location

Oncosite-Centro de Pesquisa Clinica em Oncologia

Ijuí, Rio Grande do Sul, 98700, Brazil

Location

Hospital Escola da Universidade Federal de Pelotas

Pelotas, Rio Grande do Sul, 96040-010, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital de Amor Amazonia

Porto Velho, Rondona, 76834-899, Brazil

Location

Centro Oncologico de Roraima

Boa Vista, Roraima, 69304-015, Brazil

Location

Clinica Supera

Chapecó, Santa Catarina, 89801-355, Brazil

Location

Clinica de Neoplasias Litoral - Itajai

Itajaí, Santa Catarina, 88300-000, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784, Brazil

Location

Hospital Amaral Carvalho de Jau

Jaú, São Paulo, 17210-120, Brazil

Location

Centro de Pesquisa Clinica em Hematologia e Oncologia

Santo André, São Paulo, 09060, Brazil

Location

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

São Paulo, São Paulo, 01317-001, Brazil

Location

Instituto Brasileiro de Controle do Cancer

São Paulo, São Paulo, 04014, Brazil

Location

Instituto do Cancer do Estado de San Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210036, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110001, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110101, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310020, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Cancer Institute and Hospital

Beijing, 100024, China

Location

Queen Mary Hospital

Hong Kong, 00000, Hong Kong

Location

Clinica Oncor - Centro de Infusion e Investigacion Oncologia de Satillo

Saltillo, Coahuila, 25279, Mexico

Location

Instituto Nacional de Cancerologia

Mexico City, Del Tialpan, 14080, Mexico

Location

Investigacion Biomedica para el Desarrollo de Farmacos

Zapopan, Jalisco, 45070, Mexico

Location

Sociedad Administradora de Servicios de Salud S.C.

Morelia, Michoacán, 58260, Mexico

Location

Centro Medico Zambrano Hellion

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

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

Toluca, State of Mexico, 50180, Mexico

Location

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

Aguascalientes, 20010, Mexico

Location

Centro Estatal de Cancerologia

Chihuahua City, 31000, Mexico

Location

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

Chihuahua City, 31000, Mexico

Location

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207, Mexico

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Surquillo, 15038, Peru

Location

Instituto Regional de Enfermedades Neoplasicas del Sur

Arequipa, 04002, Peru

Location

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

Lima, 15072, Peru

Location

Unidad de Investigacion - Oncologia Medica Clinica San Felipe

Lima, 15072, Peru

Location

Hospital Maria Auxiliadora

Lima, 15801, Peru

Location

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

Gdansk, 80-214, Poland

Location

Independent Public Healthcare Facility University Hospital in Cracow

Krakow, 30-688, Poland

Location

Contemporary Therapy Centre

Lodz, 90-242, Poland

Location

Polish Mother's Memorial Hospital Research Instistute

Lodz, 93-338, Poland

Location

Central Teaching Hospital of the MOI in Warsaw

Warsaw, 02-507, Poland

Location

Maria Sklodowska-Curie National Institute of Oncology

Warsaw, 02-781, Poland

Location

Nat. Research Mordovia State University

Saransk, Respublika Mordoviya, 430005, Russia

Location

SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

Arkhangelsk, 163045, Russia

Location

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

Krasnoyarsk, 660133, Russia

Location

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

Moscow, 115478, Russia

Location

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

Moscow, 143423, Russia

Location

BHI of Omsk region "Clinical Oncology Dispensary"

Omsk, 644013, Russia

Location

Orenburg Regional Clinical Oncological Center

Orenburg, 460021, Russia

Location

N.N. Petrov National Medical Research Center of Oncology

Pesochnyy, 197758, Russia

Location

LLC Medaid

Saint Petersburg, 194356, Russia

Location

SPb SBIH "City Clinical Oncological Dispensary"

Saint Petersburg, 197022, Russia

Location

Klinika Luch, Ltd.

Saint Petersburg, 197110, Russia

Location

SBHI "Volgograd Regional Oncology Dispensary #3"

Volzhskiy, 404133, Russia

Location

SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

Yaroslavl, 150054, Russia

Location

Netcare Milpark Hospital

Johannesburg, Gauteng, 2193, South Africa

Location

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

Johannesburg, Gauteng, 2193, South Africa

Location

Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, 2196, South Africa

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

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

Seoul, 06591, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

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

Suwon, 16247, South Korea

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Medical Foundation Linkou

Taipei, 10507, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 11259, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

Dnipro, 49044, Ukraine

Location

City Clinical Hospital #4

Dnipro, 49102, Ukraine

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

Kharkiv, 61166, Ukraine

Location

CI of Kherson Reg Council Kherson Regional Oncologic Dispensary

Kherson, 73000, Ukraine

Location

Medical Center of Vision Partner

Kyiv, 03002, Ukraine

Location

Medical Center Verum

Kyiv, 03039, Ukraine

Location

Kyiv Сity Clinical Oncological Center

Kyiv, 03115, Ukraine

Location

CI Reg. Oncol. Dispanser

Zhytomyr, 10002, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 40443562 DERIVED

• 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.

  PMID: 36268941 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hope Rugo, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 19, 2018
• Study Start: December 5, 2018
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9); TW (9); CN (17); ZA (3); ME (10); HK (1); PE (5); RU (13); UA (9); AU (9); US (12); BR (25); PL (6)