PER-026-21招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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).
排除标准
- •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
研究者
相似试验
招募中
不适用
The GLORIA Study: A Phase 3, Randomized, Open-Label Study of theAnti-Globo H Vaccine Adagloxad Simolenin (OBI822)/OBI-821 in the AdjuvantTreatment of Patients with HighRisk, Early-Stage Globo H-Positive TripleNegative Breast CancerKCT0005816ovotech Asia Korea668
招募中
1 期
Phase 3 Study of Adagloxad Simolenin (OBI-822)/OBI-821 Treatment for Breast Cancer PatientsTriple Negative Breast CancerMedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864CTIS2023-508755-39-00Obi Pharma Inc.668
招募中
1 期
Phase 3 Study of Adagloxad Simolenin (OBI-822)/OBI-821 Treatment for Breast Cancer PatientsTriple Negative Breast CancerMedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001438-16-PLOBI Pharma, Inc.668
进行中（未招募）
1 期
Study of efficacy and safety of the compound NGR-hTNF in patient with advanced malignant pleural mesotheliomapplicableEUCTR2009-016879-29-GBMOLMED400
进行中（未招募）
1 期
GR015: Randomized double-blind phase III study of NGR-hTNF plus best investigator s choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM) - NGR015Patients with advanced malignant pleural mesothelioma (MPM)previously treated with pemetrexedMedDRA version: 12.1Level: LLTClassification code 10035605Term: Pleural mesothelioma malignant advancedEUCTR2009-016879-29-ITMOLMED390