Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

668

Study ID:

NCT03562637

Recruitment Status:

Recruiting

Sponsor:

OBI Pharma, Inc

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There are 89 Locations for this study

See Locations Near You

Kaiser Permanente Medical Center
Harbor City California, 90710, United States More Info
OBI Investigator Site
Principal Investigator
Moores UCSD Cancer Center
La Jolla California, 92093, United States More Info
OBI Investigator Site
Principal Investigator
Long Beach Memorial Medical Center
Long Beach California, 90806, United States More Info
OBI Investigator Site
Principal Investigator
UCSF Helen Diller Family Comprehensive Cancer Centre
San Francisco California, 94158, United States More Info
OBI Investigator Site
Principal Investigator
Miami Cancer Institute
Miami Florida, 33176, United States More Info
OBI Investigator Site
Principal Investigator
University of Chicago Medical
Chicago Illinois, 60637, United States More Info
OBI Investigator Site
Principal Investigator
University of Kansas Medical Center
Westwood Kansas, 66205, United States More Info
OBI Investigator Site
Principal Investigator
University of Maryland Greenbaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States More Info
OBI Investigator Site
Principal Investigator
Henry Ford Medical Center
Detroit Michigan, 48202, United States More Info
OBI Investigator Site
Principal Investigator
North Mississippi Medical Center Hematology and Oncology Clinic
Tupelo Mississippi, 38801, United States More Info
OBI Investigator Site
Principal Investigator
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
OBI Investigator Site
Principal Investigator
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States More Info
OBI Investigator Site
Principal Investigator
Baylor Scott & White Health
Temple Texas, 76508, United States More Info
OBI Investigator Site
Principal Investigator
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States More Info
OBI Investigator Site
Principal Investigator
Westmead Hospital
Westmead New South Wales, 2145, Australia More Info
OBI Investigator Site
Principal Investigator
Breast Cancer Research Centre
Nedlands Western Australia, , Australia More Info
OBI Investigator Site
Principal Investigator
St Vincent's Hospital Sydney
Darlinghurst , 2010, Australia More Info
OBI Investigator Site
Principal Investigator
Gosford Hospital
Gosford , 2250, Australia More Info
OBI Investigator Site
Principal Investigator
St John of God Murdoch Hospital
Murdoch , 6150, Australia More Info
OBI Investigator Site
Principal Investigator
Eastern Health - Maroondah Hospital
Ringwood East , 3135, Australia More Info
OBI Investigator Site
Principal Investigator
Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Clinica de Neoplasias Litoral - Itajai
Itajaí Santa Catarina, 88300, Brazil
Hospital Amaral Carvalho de Jau
Jaú Sao Paulo, 17210, Brazil
Clinicia de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria
São Paulo Sao Paulo, 01317, Brazil
Cancer Hospital CAMS
Beijing Beijing, 10002, China More Info
OBI Investigator Site
Principal Investigator
Peking University Cancer Hospital
Beijing Beijing, 10014, China More Info
OBI Investigator Site
Principal Investigator
Sun Yat-Sen University Cancer Center
Guangzhou Guangdong, 51006, China More Info
OBI Investigator Site
Principal Investigator
The First Hospital of Guangxi Medical University
Nanning Guangxi, 53002, China More Info
OBI Investigator Site
Principal Investigator
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China More Info
OBI Investigator Site
Principal Investigator
Hubei Cancer Hospital
Wuhan Hubei, 43007, China More Info
OBI Investigator Site
Principal Investigator
Xiangya Hospital Central South University
Changsha Hunan, 41000, China More Info
OBI Investigator Site
Principal Investigator
Hunan Cancer Hospital
Changsha Hunan, 41001, China More Info
OBI Investigator Site
Principal Investigator
Jiangsu Province Hospital
Nanjing Jiangsu, 21003, China More Info
OBI Investigator Site
Principal Investigator
The First Hospital of Jilin University
Changchun Jilin, 13002, China More Info
OBI Investigator Site
Principal Investigator
Liaoning Cancer Hospital and Institute
Shenyang Liaoning, 11000, China More Info
OBI Investigator Site
Principal Investigator
The First Hospital of China Medical University
Shenyang Liaoning, 11010, China More Info
OBI Investigator Site
Principal Investigator
Sichuan Provincial People's Hospital
Chengdu Sichuan, 61007, China More Info
OBI Investigator Site
Principal Investigator
Tianjin Cancer Hospital
Tianjin Tianjin, 30006, China More Info
OBI Investigator Site
Principal Investigator
Sir Run Run Shaw Hospital
Hangzhou Zhejiang, 31002, China More Info
OBI Investigator Site
Principal Investigator
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China More Info
OBI Investigator Site
Principal Investigator
Cancer Institute and Hospital
Beijing , 10002, China More Info
OBI Investigator Site
Principal Investigator
Queen Mary Hospital
Hong Kong , 00000, Hong Kong More Info
OBI Investigator Site
Principal Investigator
The University of Hong Kong
Hong Kong , 00000, Hong Kong More Info
OBI Investigator Site
Principal Investigator
Dong-A University Hospital
Busan , 49201, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
National Cancer Center
Goyang-si , 10408, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
Inha University Hospital
Incheon , 22332, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
Asan Medical Center
Seoul , 05505, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si , 16247, Korea, Republic of More Info
OBI Investigator Site
Principal Investigator
Icaro Investigaciones en Medicina S.A. de C.V.
Chihuahua , 31000, Mexico
Nat. Research Mordovia State University
Saransk Republic Of Mordovia, 43000, Russian Federation More Info
OBI Investigator Site
Principal Investigator
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk , 16304, Russian Federation More Info
OBI Investigator Site
Principal Investigator
LLC Evimed
Chelyabinsk , 45404, Russian Federation
Krasnoyarsk Territorial Clinical Oncology Center named after A.I. Kryzhanovsky
Krasnoyarsk , 66013, Russian Federation More Info
OBI Investigator Site
Principal Investigator
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow , 11547, Russian Federation More Info
OBI Investigator Site
Principal Investigator
SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare department
Moscow , 14342, Russian Federation More Info
OBI Investigator Site
Principal Investigator
SBIH of Nizhniy Novgorod region
Nizhny Novgorod , 60300, Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk , 64401, Russian Federation More Info
OBI Investigator Site
Principal Investigator
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
Pesochnyy , 19775, Russian Federation
N.N. Petrov National Medical Research Center of Oncology
Pesochnyy , 19775, Russian Federation More Info
OBI Investigator Site
Principal Investigator
LLC Medaid
Saint Petersburg , 19435, Russian Federation More Info
OBI Investigator Site
Principal Investigator
SPb SBIH "City Clinical Oncological Dispensary"
Saint-Petersburg , 19702, Russian Federation More Info
OBI Investigator Site
Principal Investigator
Klinika Luch, Ltd.
St. Petersburg , 19711, Russian Federation More Info
OBI Investigator Site
Principal Investigator
SI "SRI of Oncology of Tomsk RC of Siberian Branch of RAMS"
Tomsk , 63400, Russian Federation
SBHI "Volgograd Regional Oncology Dispensary #3"
Volzhskiy , 40413, Russian Federation More Info
OBI Investigator Site
Principal Investigator
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl , 15005, Russian Federation More Info
OBI Investigator Site
Principal Investigator
Netcare Milpark Hospital
Johannesburg Gauteng, 2193, South Africa
Wits Clinical Research, a division of Wits Health Consortium (Pty) Ltd
Johannesburg Gauteng, 2193, South Africa
Medical Oncology Centre of Rosebank
Johannesburg Gauteng, 2196, South Africa More Info
OBI Investigator Site
Principal Investigator
Changhua Christian Hospital
Changhua , 500, Taiwan More Info
OBI Investigator Site
Principal Investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan More Info
OBI Investigator Site
Principal Investigator
China Medical University Hospital
Taichung , 40447, Taiwan More Info
OBI Investigator Site
Principal Investigator
Chung Shan Medical University
Taichung , , Taiwan More Info
OBI Site Investigator
Principal Investigator
National Cheng Kung University Hospital
Tainan , 704, Taiwan More Info
OBI Investigator Site
Principal Investigator
National Taiwan University Hospital
Taipei , 100, Taiwan More Info
OBI Investigator Site
Principal Investigator
Chang Gung Memorial Hospital, Taipei
Taipei , 10507, Taiwan More Info
OBI Investigator Site
Principal Investigator
Taipei Veterans General Hospital
Taipei , 11217, Taiwan More Info
OBI Investigator Site
Principal Investigator
Koo Foundation Sun Yat-Sen Cancer Center
Taipei , 11259, Taiwan More Info
OBI Investigator Site
Principal Investigator
Tri-Service General Hospital
Taipei , 11490, Taiwan More Info
OBI Investigator Site
Principal Investigator
Mackay Memorial Hospital
Taipei , , Taiwan More Info
OBI Site Investigator
Principal Investigator
Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
Dnipro , 49044, Ukraine More Info
OBI Investigator Site
Principal Investigator
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk , 76018, Ukraine More Info
OBI Investigator Site
Principal Investigator
Grigoriev Institute for Medical Radiology and Oncology of the NAMSU
Kharkiv , 61024, Ukraine More Info
OBI Investigator Site
Principal Investigator
Regional Center of Oncology
Kharkiv , 61070, Ukraine More Info
OBI Investigator Site
Principal Investigator
CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
Kharkiv , 61166, Ukraine More Info
OBI Investigator Site
Principal Investigator
CI of Kherson Reg Council Kherson Regional Oncologic Dispensary
Kherson , 73000, Ukraine More Info
OBI Investigator Site
Principal Investigator
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih , 50048, Ukraine
First Private Clinic
Kyiv , 03037, Ukraine More Info
OBI Investigator Site
Principal Investigator
Medical Center Verum
Kyiv , 03039, Ukraine More Info
OBI Investigator Site
Principal Investigator
Kyiv Сity Clinical Oncological Center
Kyiv , 03115, Ukraine More Info
OBI Investigator Site
Principal Investigator
Treatment-Prevention Institution Volyn Regional Oncological Dispensary
Lutsk , 43018, Ukraine
Odesa Regional Oncologic Dispensary
Odesa , 65055, Ukraine
CI Zaporizhzhia Regional Clinical Oncological Dispensary of ZRC
Zaporizhzhia , 69040, Ukraine
CI Reg. Oncol. Dispanser
Zhytomyr , 10002, Ukraine More Info
OBI Investigator Site
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

668

Study ID:

NCT03562637

Recruitment Status:

Recruiting

Sponsor:


OBI Pharma, Inc

How clear is this clinincal trial information?

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