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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2027
  • participants needed
    668
  • sponsor
    OBI Pharma, Inc
Updated on 22 November 2021
cancer
estrogen
growth factor
gilbert's syndrome
progesterone
anthracyclines
metastasis
neutrophil count
capecitabine
epidermal growth factor receptor
HER2
chemotherapy regimen
alopecia
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor
invasive breast cancer
taxane
adjuvant chemotherapy
serum total bilirubin
renal function test

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.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment Standard of Care Treatment, adagloxad simolenin combined with OBI-821, Phosphate-buffered saline (PBS), Globo H IHC Assay
Clinical Study IdentifierNCT03562637
SponsorOBI Pharma, Inc
Last Modified on22 November 2021

Eligibility

Yes No Not Sure

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/L
Platelets 75,000/L
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
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