PER-026-21RecruitingPhase 3
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
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- OBI PHARMA, INC
- Enrollment
- 13
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •15. Ability to understand and willingness to complete all protocol required procedures.
- •14. 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.
- •5. No evidence of metastatic disease in chest, abdomen and pelvis by CT or other adequate imaging 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
- •4. Globo H IHC H-score =15 from the residual primary site/or lymph node (if primary site is not available) tumor obtained at the 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 Section 9.1.1 and the study Lab Manual.
- •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 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.
- •2. Documented radiographic and histopathologic confirmed primary localized invasive breast cancer.
- •13. Adequate hematological, hepatic and renal function as defined below:
- •-Absolute neutrophil count (ANC) =1,500/microliters
- •- Platelets =75,000/microliters
- •-Hemoglobin =8.5 g/dL
- •- Serum creatinine =1.5 × upper limit of normal (ULN) or calculated creatinine clearance =55 mL/min for patients 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).
Exclusion Criteria
- •16. Currently participating in or has participated in a breast cancer therapeutic clinical trial within 4 weeks (28 days) prior to randomization
- •15. Currently pregnant or breastfeeding women.
- •14. Any condition, including significant diseases and/or laboratory abnormalities that would place the patient at unacceptable risk for study participation
- •13. 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)
- •12. 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 is not required for study entry)
- •11. Prior receipt of a glycoconjugate vaccine for cancer immunotherapy
- •10. Any known hypersensitivity to active/inactive ingredients in the study drug formulation or known severe allergy or anaphylaxis to fusion proteins
- •9. 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
- •8. 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.
- •7. 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.
- •6. 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.
- •5. 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.
- •4. Have received any post-operative immunotherapy
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