Clinical Trials List
Protocol NumberOBI-822-011
NCT Number(ClinicalTrials.gov Identfier)NCT03562637
2018-12-01 - 2025-11-30
Phase III
Recruiting12
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
ICD-9174.9
Malignant neoplasm of female breast, unspecified
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
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Trial Applicant
OBI PHARMA, INC.
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Sponsor
OBI Pharma, Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 饒坤銘 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張源清 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 甘蓉瑜 Division of General Surgery
- 高捷妮 未分科
- Fu Ouyang Division of General Surgery
- Chung-Liang Li Division of General Surgery
- Chieh-Han Chuang Division of General Surgery
- 巫承哲 Division of General Surgery
- Fang-Ming Chen Division of General Surgery
- Shen Liang Shih Division of General Surgery
- Junping Shiau Shiau 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
High-Risk, Early-Stage Globo H-Positive Triple Negative Breast Cancer
Objectives
Primary objective:
1. To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on
improving invasive disease-free survival (IDFS) in the study population.
Secondary objectives:
1. To determine the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in
TNBC patients at high risk for relapse, on:
a. Overall Survival (OS)
b. Quality of Life (QoL)
2. To determine safety and tolerability of adagloxad simolenin (OBI-822)/OBI-821 in
the study population.
Test Drug
Adagloxad simolenin (OBI-822)/OBI-821
Active Ingredient
OBI-821 (adjuvant)
OBI-822: Globo H-Keyhole Limpet Hemocyanin [KLH]
OBI-822: Globo H-Keyhole Limpet Hemocyanin [KLH]
Dosage Form
Lyophilized powder for injection
Lyophilized powder for injection
Lyophilized powder for injection
Dosage
37.5 µg
150 µg
150 µg
Endpoints
Primary Outcome Measures :
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.
Secondary Outcome Measures :
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
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).
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
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
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).
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.
Secondary Outcome Measures :
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
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).
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
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
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).
Inclution Criteria
Inclusion Criteria: Subjects are included if they meet all of the following inclusion criteria:
1. Male or female subject ≥18 years.
2. Documented radiographic and histopathologic confirmed primary localized invasive breast cancer.
3. Histologically documented TNBC (ER-/PR-/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 biopsy sample from surgery.
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 FISH HER2/neu chromosome 17 (CEP17) non-amplified ratio of <2
4. Globo H IHC H-score ≥15 in the tumor tissue biopsy from the primary site/or lymph
node (if primary site is not available). The Globo H expression will be determined
during Pre-screening Phase by Central lab. Instructions for submission of
slides/tumor tissues block and pertinent reports to central review are provided in the study Lab Manual.
5. No evidence of metastatic disease in chest, abdomen and pelvis by CT or MRI scan
during the Screening Phase. Historical report 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.
6. High risk patients meeting ONE of the following criteria:
Neoadjuvant chemotherapy: Residual invasive disease following neoadjuvant
chemotherapy defined as: A contiguous focus of residual invasive cancer in the
breast measuring ≥1 cm in diameter with more than 1% cellularity and/or with
residual invasive cancer in at least one axillary node (as determined by local pathology review)
Primary surgery: Patients must have ≥4 axillary lymph nodes positive for invasive
cancer and have completed adjuvant chemotherapy
7. Must have completed taxane (with or without platinum), and/or anthracyclinebased chemotherapy (either sequential or concurrent) either in the neoadjuvant or adjuvant setting.
Post-neoadjuvant chemotherapy with capecitabine or a platinum salt is allowed.
8. Surgery for treatment of primary cancer must be completed at least 2 weeks, but no
more than 56 weeks, prior to randomization. Patients receiving neoadjuvant
therapy who are not receiving post-operative (adjuvant) chemotherapy must have
completed their final breast surgery no more than 32 weeks prior to randomization.
9. All adjuvant chemotherapy and/or radiotherapy (if indicated) after surgery, must
have been completed at least 2 weeks prior to randomization.
10. 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).
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
12. 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.
13. Males and females of childbearing potential and their partners must be willing to use
effective contraception during the entire study treatment period (Section 9.4.9) and
for at least 8 weeks after the last dose of study treatment.
14. 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)
15. Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal,
by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
16. Consent to participate with a signed and dated IRB-approved patient informed
consent for the study prior to beginning any specific study procedures.
17. Ability to understand and willingness to complete all protocol required procedures.
1. Male or female subject ≥18 years.
2. Documented radiographic and histopathologic confirmed primary localized invasive breast cancer.
3. Histologically documented TNBC (ER-/PR-/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 biopsy sample from surgery.
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 FISH HER2/neu chromosome 17 (CEP17) non-amplified ratio of <2
4. Globo H IHC H-score ≥15 in the tumor tissue biopsy from the primary site/or lymph
node (if primary site is not available). The Globo H expression will be determined
during Pre-screening Phase by Central lab. Instructions for submission of
slides/tumor tissues block and pertinent reports to central review are provided in the study Lab Manual.
5. No evidence of metastatic disease in chest, abdomen and pelvis by CT or MRI scan
during the Screening Phase. Historical report 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.
6. High risk patients meeting ONE of the following criteria:
Neoadjuvant chemotherapy: Residual invasive disease following neoadjuvant
chemotherapy defined as: A contiguous focus of residual invasive cancer in the
breast measuring ≥1 cm in diameter with more than 1% cellularity and/or with
residual invasive cancer in at least one axillary node (as determined by local pathology review)
Primary surgery: Patients must have ≥4 axillary lymph nodes positive for invasive
cancer and have completed adjuvant chemotherapy
7. Must have completed taxane (with or without platinum), and/or anthracyclinebased chemotherapy (either sequential or concurrent) either in the neoadjuvant or adjuvant setting.
Post-neoadjuvant chemotherapy with capecitabine or a platinum salt is allowed.
8. Surgery for treatment of primary cancer must be completed at least 2 weeks, but no
more than 56 weeks, prior to randomization. Patients receiving neoadjuvant
therapy who are not receiving post-operative (adjuvant) chemotherapy must have
completed their final breast surgery no more than 32 weeks prior to randomization.
9. All adjuvant chemotherapy and/or radiotherapy (if indicated) after surgery, must
have been completed at least 2 weeks prior to randomization.
10. 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).
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
12. 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.
13. Males and females of childbearing potential and their partners must be willing to use
effective contraception during the entire study treatment period (Section 9.4.9) and
for at least 8 weeks after the last dose of study treatment.
14. 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)
15. Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal,
by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
16. Consent to participate with a signed and dated IRB-approved patient informed
consent for the study prior to beginning any specific study procedures.
17. Ability to understand and willingness to complete all protocol required procedures.
Exclusion Criteria
Exclusion criteria:
Subjects are excluded if they meet any of the following exclusion criteria:
1. Local recurrence of or previous history of contralateral invasive breast cancer within
10 years of the current diagnosis.
2. Definitive clinical or radiologic evidence of metastatic disease
3. Synchronous bilateral breast cancer, unless both tumors are confirmed as TNBC.
4. Have received any systemic treatment for TNBC within 2 weeks prior to randomization.
5. Have received neo/adjuvant anti-cancer treatment or immunotherapy with antigen,
antibody, immune checkpoint inhibitors (Programmed cell death-1/ Programmed cell
death-ligand-1inhibitors, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4] therapy), or other anti-cancer vaccines within 4 weeks prior to randomization.
6. For patients undergoing neoadjuvant chemotherapy, more than one line of chemotherapy following surgery.
7. A history of other malignancies (except non-melanoma skin carcinoma, carcinoma
in situ of the uterine cervix, non-invasive follicular thyroid neoplasm and papillary
thyroid cancer) within 5 years prior to this breast cancer diagnosis.
8. 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.
9. 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.
10. 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.
11. Any known hypersensitivity to active/inactive ingredients in the study drug
formulation or known severe allergy or anaphylaxis to fusion proteins.
12. Receipt of any live, attenuated vaccine (including influenza vaccine, e.g., FluMist)
within 4 weeks prior to randomization and during the study till 4 weeks after the last
dose of study treatment. NOTE: inactivated vaccines (e.g., inactivated influenza
vaccines) are allowed during the study, if required.
13. Prior receipt of a glycoconjugate vaccine.
14. Known history or positive for human immunodeficiency virus (HIV positive)
15. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at
screening. Active infections are HBVsAg positive, HBV DNA ≥1000 cps/mL or 200 IU/mL or positive HCV RNA test.
16. Any condition, including significant diseases and/or laboratory abnormalities that
would place the subject at unacceptable risk for study participation.
17. Currently pregnant or breastfeeding women.
18. Currently participating in a clinical study, and receiving an investigational drug or
has participated in a therapeutic clinical trial within 4 weeks prior to randomization
Subjects are excluded if they meet any of the following exclusion criteria:
1. Local recurrence of or previous history of contralateral invasive breast cancer within
10 years of the current diagnosis.
2. Definitive clinical or radiologic evidence of metastatic disease
3. Synchronous bilateral breast cancer, unless both tumors are confirmed as TNBC.
4. Have received any systemic treatment for TNBC within 2 weeks prior to randomization.
5. Have received neo/adjuvant anti-cancer treatment or immunotherapy with antigen,
antibody, immune checkpoint inhibitors (Programmed cell death-1/ Programmed cell
death-ligand-1inhibitors, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4] therapy), or other anti-cancer vaccines within 4 weeks prior to randomization.
6. For patients undergoing neoadjuvant chemotherapy, more than one line of chemotherapy following surgery.
7. A history of other malignancies (except non-melanoma skin carcinoma, carcinoma
in situ of the uterine cervix, non-invasive follicular thyroid neoplasm and papillary
thyroid cancer) within 5 years prior to this breast cancer diagnosis.
8. 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.
9. 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.
10. 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.
11. Any known hypersensitivity to active/inactive ingredients in the study drug
formulation or known severe allergy or anaphylaxis to fusion proteins.
12. Receipt of any live, attenuated vaccine (including influenza vaccine, e.g., FluMist)
within 4 weeks prior to randomization and during the study till 4 weeks after the last
dose of study treatment. NOTE: inactivated vaccines (e.g., inactivated influenza
vaccines) are allowed during the study, if required.
13. Prior receipt of a glycoconjugate vaccine.
14. Known history or positive for human immunodeficiency virus (HIV positive)
15. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at
screening. Active infections are HBVsAg positive, HBV DNA ≥1000 cps/mL or 200 IU/mL or positive HCV RNA test.
16. Any condition, including significant diseases and/or laboratory abnormalities that
would place the subject at unacceptable risk for study participation.
17. Currently pregnant or breastfeeding women.
18. Currently participating in a clinical study, and receiving an investigational drug or
has participated in a therapeutic clinical trial within 4 weeks prior to randomization
The Estimated Number of Participants
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Taiwan
60 participants
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Global
668 participants
