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

February 23, 2024 updated by: OBI Pharma, Inc

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

668

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Darlinghurst, Australia, 2010
        • Recruiting
        • St Vincent's Hospital Sydney
        • Principal Investigator:
          • OBI Investigator Site
      • Gosford, Australia, 2250
        • Recruiting
        • Gosford Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Murdoch, Australia, 6150
        • Recruiting
        • St John of God Murdoch Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Ringwood East, Australia, 3135
        • Recruiting
        • Eastern Health - Maroondah Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Queensland
      • Urraween, Queensland, Australia, 4655
        • Recruiting
        • Cancer Care Service, Hervey Bay Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Slade Pharmacy
        • Principal Investigator:
          • OBI Investigator Site
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • Cabrini Malvern
        • Principal Investigator:
          • OBI Investigator Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Recruiting
        • Breast Cancer Research Centre
        • Principal Investigator:
          • OBI Investigator Site
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41253-90
        • Recruiting
        • Hospital Sao Rafael
        • Principal Investigator:
          • OBI Investigator Site
    • Ceara
      • Fortaleza, Ceara, Brazil, 60810
        • Recruiting
        • Suporte Nutricional e Quimioterapia
        • Principal Investigator:
          • OBI Investigator Site
    • Espirito Santo
      • Serra, Espirito Santo, Brazil, 29160-750
        • Recruiting
        • Centro de Avaliacao de Medicamentos e Especialidades de Pesquisa
        • Principal Investigator:
          • OBI Investigator Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30380-472
        • Recruiting
        • Instituto Mario Penna
        • Principal Investigator:
          • OBI Investigator Site
    • Para
      • Belém, Para, Brazil, 66073-005
        • Recruiting
        • Centro de Tratamento Oncologico LTDA - CTO
        • Principal Investigator:
          • OBI Investigator Site
    • Parana
      • Campo Largo, Parana, Brazil, 83606-177
        • Recruiting
        • Maternidade e Cirurgia Nossa Senhora do Rocio
        • Principal Investigator:
          • OBI Investigator Site
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52010-075
        • Recruiting
        • Real Hospital Portugues de Beneficencia de Pernambuco
        • Principal Investigator:
          • OBI Investigator Site
      • Recife, Pernambuco, Brazil, 52010-000
        • Recruiting
        • Hospital do Capibaribe
        • Principal Investigator:
          • OBI Investigator Site
    • Piaui
      • Teresina, Piaui, Brazil, 64049-200
        • Recruiting
        • Centro de Pesquisa Vencer & Oncolinca
        • Principal Investigator:
          • OBI Investigator Site
    • Rio Grande Do Sul
      • Barretos, Rio Grande Do Sul, Brazil
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Principal Investigator:
          • OBI Investigator Site
      • Ijuí, Rio Grande Do Sul, Brazil, 98700
        • Recruiting
        • Oncosite-Centro de Pesquisa Clinica em Oncologia
        • Principal Investigator:
          • OBI Investigator Site
      • Pelotas, Rio Grande Do Sul, Brazil, 96040-010
        • Recruiting
        • Hospital Escola da Universidade Federal de Pelotas
        • Principal Investigator:
          • OBI Investigator Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Recruiting
        • Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Recruiting
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
        • Principal Investigator:
          • OBI Investigator Site
    • Rondona
      • Porto Velho, Rondona, Brazil, 76834-899
        • Recruiting
        • Hospital de Amor Amazônia
        • Principal Investigator:
          • OBI Investigator Site
    • Roraima
      • Boa Vista, Roraima, Brazil, 69304-015
        • Recruiting
        • Centro Oncológico De Roraima
        • Principal Investigator:
          • OBI Investigator Site
    • Santa Catarina
      • Chapeco, Santa Catarina, Brazil, 89801-355
        • Recruiting
        • Clinica Supera
        • Principal Investigator:
          • OBI Investigator Site
      • Itajaí, Santa Catarina, Brazil, 88300-000
        • Recruiting
        • Clinica de Neoplasias Litoral - Itajai
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784
        • Recruiting
        • Hospital de Cancer de Barretos
        • Principal Investigator:
          • OBI Investigator Site
      • Jaú, Sao Paulo, Brazil, 17210-120
        • Recruiting
        • Hospital Amaral Carvalho de Jaù
      • Santo André, Sao Paulo, Brazil, 09060
        • Recruiting
        • Centro de Pesquisa Clinica em Hematologia e Oncologia
        • Principal Investigator:
          • OBI Investigator Site
      • São Paulo, Sao Paulo, Brazil, 01317-001
        • Recruiting
        • Clinicia de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria
      • São Paulo, Sao Paulo, Brazil, 04014
        • Recruiting
        • Instituto Brasileiro de Controle do Cancer
        • Principal Investigator:
          • OBI Investigator Site
      • São Paulo, Sao Paulo, Brazil, 05403-900
        • Recruiting
        • Instituto do Cancer do Estado de San Paulo
        • Principal Investigator:
          • OBI Investigator Site
  • China
      • Beijing, China, 100024
        • Not yet recruiting
        • Cancer Institute and Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital CAMS
        • Principal Investigator:
          • OBI Investigator Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Principal Investigator:
          • OBI Investigator Site
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Hospital of Guangxi Medical University
        • Principal Investigator:
          • OBI Investigator Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Principal Investigator:
          • OBI Investigator Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210036
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Principal Investigator:
          • OBI Investigator Site
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • Liaoning Cancer Hospital and Institute
        • Principal Investigator:
          • OBI Investigator Site
      • Shenyang, Liaoning, China, 110101
        • Recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • OBI Investigator Site
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Principal Investigator:
          • OBI Investigator Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Hangzhou, Zhejiang, China, 310020
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Principal Investigator:
          • OBI Investigator Site
  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • Recruiting
        • Queen Mary Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Hong Kong, Hong Kong, 00000
        • Recruiting
        • The University of Hong Kong
        • Principal Investigator:
          • OBI Investigator Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Recruiting
        • Dong-A University Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Goyang-si, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
        • Principal Investigator:
          • OBI Investigator Site
      • Incheon, Korea, Republic of, 22332
        • Recruiting
        • Inha University Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Seongnam-si, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • OBI Investigator Site
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • OBI Investigator Site
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • OBI Investigator Site
      • Suwon-si, Korea, Republic of, 16247
        • Recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
        • Principal Investigator:
          • OBI Investigator Site
  • Mexico
      • Chihuahua, Mexico, 31000
        • Recruiting
        • Icaro Investigaciones en Medicina S.A. de C.V.
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25279
        • Recruiting
        • Clinica Oncor - Centro de Infusion e Investigacion Oncologia de Satillo
        • Principal Investigator:
          • OBI Investigator Site
    • Del Tialpan
      • Ciudad de mexico, Del Tialpan, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Principal Investigator:
          • OBI Investigator Site
    • Nuevo Leon
      • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
        • Recruiting
        • Centro Medico Zambrano Hellion
        • Principal Investigator:
          • OBI Investigator Site
  • Peru
      • Arequipa, Peru, 04002
        • Recruiting
        • Instituto Regional de Enfermedades Neoplasicas del Sur
        • Principal Investigator:
          • OBI Investigator Site
      • Lima, Peru, 15072
        • Recruiting
        • Hospital Nacional Edgardo Rebagliati Martins, Unidad de Investigacion de Oncologia Medica
        • Principal Investigator:
          • OBI Investigator Site
      • Lima, Peru, 15072
        • Recruiting
        • Unidad de Investigacion - Oncologia Medica Clinica San Felipe
        • Principal Investigator:
          • OBI Investigator Site
    • Surquillo
      • Lima, Surquillo, Peru, 15038
        • Recruiting
        • Instituto Nacional de Enfermedades Neoplasicas
        • Principal Investigator:
          • OBI Investigator Site
  • Poland
      • Gdańsk, Poland, 80-214
        • Recruiting
        • University Clinical Centre - Hospital, Teaching Dept of Oncology and Radiotherapy
        • Principal Investigator:
          • OBI Investigator Site
      • Kraków, Poland, 30-688
        • Recruiting
        • Independent Public Healthcare Facility University Hospital in Cracow
        • Principal Investigator:
          • OBI Investigator Site
      • Warsaw, Poland, 02-507
        • Recruiting
        • Central Teaching Hospital of the MOI in Warsaw
        • Principal Investigator:
          • OBI Investigator Site
      • Warsaw, Poland, 02-781
        • Recruiting
        • Maria Sklodowska-Curie National Institute of Oncology
        • Principal Investigator:
          • OBI Investigator Site
      • Łódź, Poland, 90-242
        • Recruiting
        • Contemporary Therapy Centre
        • Principal Investigator:
          • OBI Investigator Site
      • Łódź, Poland, 93-338
        • Recruiting
        • Polish Mother's Memorial Hospital Research Instistute
        • Principal Investigator:
          • OBI Investigator Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Recruiting
        • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
        • Principal Investigator:
          • OBI Investigator Site
      • Chelyabinsk, Russian Federation, 454048
        • Withdrawn
        • LLC Evimed
      • Krasnoyarsk, Russian Federation, 660133
        • Recruiting
        • Krasnoyarsk Territorial Clinical Oncology Center named after A.I. Kryzhanovsky
        • Principal Investigator:
          • OBI Investigator Site
      • Moscow, Russian Federation, 115478
        • Recruiting
        • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
        • Principal Investigator:
          • OBI Investigator Site
      • Moscow, Russian Federation, 143423
        • Recruiting
        • SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare department
        • Principal Investigator:
          • OBI Investigator Site
      • Nizhny Novgorod, Russian Federation, 603005
        • Withdrawn
        • SBIH of Nizhniy Novgorod region
      • Omsk, Russian Federation, 644013
        • Recruiting
        • BHI of Omsk region "Clinical oncology dispensary"
        • Principal Investigator:
          • OBI Investigator Site
      • Orenburg, Russian Federation, 460021
        • Recruiting
        • Orenburg Regional Clinical Oncological Center
        • Principal Investigator:
          • OBI Investigator Site
      • Pesochnyy, Russian Federation, 197758
        • Withdrawn
        • FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
      • Pesochnyy, Russian Federation, 197758
        • Recruiting
        • N.N. Petrov National Medical Research Center of Oncology
        • Principal Investigator:
          • OBI Investigator Site
      • Saint Petersburg, Russian Federation, 194356
        • Recruiting
        • LLC Medaid
        • Principal Investigator:
          • OBI Investigator Site
      • Saint-Petersburg, Russian Federation, 197022
        • Recruiting
        • SPb SBIH "City Clinical Oncological Dispensary"
        • Principal Investigator:
          • OBI Investigator Site
      • St. Petersburg, Russian Federation, 197110
        • Recruiting
        • Klinika Luch, Ltd.
        • Principal Investigator:
          • OBI Investigator Site
      • Tomsk, Russian Federation, 634009
        • Withdrawn
        • SI "SRI of Oncology of Tomsk RC of Siberian Branch of RAMS"
      • Volzhskiy, Russian Federation, 404133
        • Recruiting
        • SBHI "Volgograd Regional Oncology Dispensary #3"
        • Principal Investigator:
          • OBI Investigator Site
      • Yaroslavl, Russian Federation, 150054
        • Recruiting
        • SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
        • Principal Investigator:
          • OBI Investigator Site
    • Republic Of Mordovia
      • Saransk, Republic Of Mordovia, Russian Federation, 430005
        • Recruiting
        • Nat. Research Mordovia State University
        • Principal Investigator:
          • OBI Investigator Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Netcare Milpark Hospital
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Wits Clinical Research, a division of Wits Health Consortium (Pty) Ltd
      • Johannesburg, Gauteng, South Africa, 2196
        • Recruiting
        • Medical Oncology Centre of Rosebank
        • Principal Investigator:
          • OBI Investigator Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Taichung, Taiwan
        • Recruiting
        • Chung Shan Medical University
        • Principal Investigator:
          • OBI Investigator Site
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Taipei, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Taipei, Taiwan, 11490
        • Recruiting
        • Tri-Service General Hospital
        • Principal Investigator:
          • OBI Investigator Site
      • Taipei, Taiwan, 11259
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center
        • Principal Investigator:
          • OBI Investigator Site
      • Taipei, Taiwan, 10507
        • Recruiting
        • Chang Gung Memorial Hospital, Taipei
        • Principal Investigator:
          • OBI Investigator Site
  • Ukraine
      • Dnipro, Ukraine, 49044
        • Recruiting
        • Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
        • Principal Investigator:
          • OBI Investigator Site
      • Dnipro, Ukraine, 49102
        • Active, not recruiting
        • City Clinical Hospital #4
      • Ivano-Frankivsk, Ukraine, 76018
        • Active, not recruiting
        • CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU
      • Kharkiv, Ukraine, 61024
        • Active, not recruiting
        • Grigoriev Institute for Medical Radiology and Oncology of the NAMSU
      • Kharkiv, Ukraine, 61070
        • Active, not recruiting
        • Regional Center of Oncology
      • Kharkiv, Ukraine, 61166
        • Active, not recruiting
        • Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
      • Kherson, Ukraine, 73000
        • Active, not recruiting
        • CI of Kherson Reg Council Kherson Regional Oncologic Dispensary
      • Kryvyi Rih, Ukraine, 50048
        • Withdrawn
        • CI Kryvyi Rih Oncological Dispensary of DRC
      • Kyiv, Ukraine, 03002
        • Active, not recruiting
        • Medical Center of Vision Partner
      • Kyiv, Ukraine, 03037
        • Active, not recruiting
        • First Private Clinic
      • Kyiv, Ukraine, 03039
        • Active, not recruiting
        • Medical Center Verum
      • Kyiv, Ukraine, 03115
        • Active, not recruiting
        • Kyiv Сity Clinical Oncological Center
      • Lutsk, Ukraine, 43018
        • Withdrawn
        • Treatment-Prevention Institution Volyn Regional Oncological Dispensary
      • Odesa, Ukraine, 65055
        • Withdrawn
        • Odesa Regional Oncologic Dispensary
      • Zaporizhzhia, Ukraine, 69040
        • Withdrawn
        • CI Zaporizhzhia Regional Clinical Oncological Dispensary of ZRC
      • Zhytomyr, Ukraine, 10002
        • Active, not recruiting
        • CI Reg. Oncol. Dispanser
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • Moores UCSD Cancer Center
        • Principal Investigator:
          • OBI Investigator Site
      • San Diego, California, United States, 92120
        • Recruiting
        • Kaiser Permanente Medical Center
        • Principal Investigator:
          • OBI Investigator Site
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Centre
        • Principal Investigator:
          • OBI Investigator Site
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Principal Investigator:
          • OBI Investigator Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical
        • Principal Investigator:
          • OBI Investigator Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Greenbaum Comprehensive Cancer Center
        • Principal Investigator:
          • OBI Investigator Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Medical Center
        • Principal Investigator:
          • OBI Investigator Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Withdrawn
        • North Mississippi Medical Center Hematology and Oncology Clinic
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • OBI Investigator Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Principal Investigator:
          • OBI Investigator Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties, PLLC
        • Principal Investigator:
          • OBI Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. 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 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 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 a standard taxane, and/or anthracycline-based multi-agent chemotherapy regimen either in the neoadjuvant or adjuvant setting (e.g., National Comprehensive Cancer Network recommended regimens):.

    • At least 4 cycles of a standard multi-agent chemotherapy regimen must have been received, unless precluded by toxicities
    • Post operative adjuvant capecitabine or a platinum monotherapy in patients with residual disease after neoadjuvant chemotherapy is allowed.
  • Randomization must occur within 12 weeks after completion of standard of care treatment (surgery and/or chemotherapy) and within 46 weeks from the date of definitive surgery. Note: patients receiving adjuvant capecitabine or platinum monotherapy after neoadjuvant multi-agent chemotherapy may be randomized and initiate study treatment during (or within 12 weeks after completion of) the adjuvant capecitabine or platinum monotherapy.
  • 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 of 0 or 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 randomization.
  • Males and females of childbearing potential and their partners must be willing to use effective contraception during the entire Treatment Phase period 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.
  • Definitive clinical or radiologic evidence of metastatic disease
  • Synchronous bilateral breast cancer, unless both tumors are confirmed as TNBC.
  • Have received any post-operative immunotherapy with antigen, antibody, immune checkpoint inhibitors (Programmed cell death-1 [PD-1]/ Programmed cell death-ligand-1inhibitors [PD-L-1], anti-cytotoxic T lymphocyte associated protein 4 [CTLA 4] therapy), or other anti-cancer vaccines (neoadjuvant receipt of immune checkpoint inhibitors will not be exclusionary if the patient meets all other eligibility criteria).
  • Concomitant treatment with approved anticancer therapy or immunotherapy including checkpoint inhibitors (e.g. PD-1 inhibitors) or other investigational therapy, if expected during the study. Adjuvant capecitabine or platinum monotherapy is allowed during the study.
  • A history of other malignancies (except non melanoma skin carcinoma, carcinoma in situ of the uterine cervix, follicular or papillary thyroid cancer) 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 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 (24 days) prior to randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 5 years
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).
Time Frame: 7 years
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).
Time Frame: 7 years

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).
Time Frame: 7 years
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).
Time Frame: 7 years
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.]
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

OBI Pharma, Inc

Investigators

  • Study Chair: Hope Rugo, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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