None listed
Conditions
Interventions
Drug : ? Adagloxad simolenin (OBI-822)/OBI-821 plus SOC(Standard of care) arm (Arm 1): Patients will receive up to a total of 21 subcutaneous injections of adagloxad simolenin (OBI-822)/OBI-821 over a
Sponsors
Novotech Asia Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients are included if they meet all of the following inclusion criteria: 1. Male or female patient =18 years. 2. Documented radiographic and histopathologic confirmed primary localized invasivebreast cancer. 3. Histologically documented TNBC (estrogen receptor-negative [ER-] / progesteronereceptor-negative [PR-] / human epidermal growth factor 2-negatove [HER2-])defined as ER-negative and PR-negative (=5% positive cells stain by IHC for bothER 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 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 forsubmission of slides/tumor tissue blocks are provided in the protocol and study LabManual. 5. No evidence of metastatic disease in chest, abdomen, and pelvis by CT or otheradequate imaging during the Screening Phase. Imaging within 3 months prior torandomization is acceptable as baseline scan. Bone scans and imaging of the brainat screening is optional, and should be symptom directed. 6. 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 invasivedisease following neoadjuvant chemotherapy defined as: A contiguous focus of residual invasive cancer in the surgical breast specimen 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(pT2N1 or pT3N0), Stage IIIA (pT0-3N2 or pT3N1), IIIB (T4N0-2), orStage IIIC (T0-3N3) disease according to the 8th edition of the American JointCommittee on Cancer (AJCC) Cancer Staging Manual. 7. 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 listed in Section 2.3): • At least 4 cycles of a standard multi-agent chemotherapy regimen must have been received, unless precluded by toxicities. • Postoperative adjuvant capecitabine or platinum monotherapy in patients withresidual disease after neoadjuvant chemotherapy is allowed. 8. Randomization must occur within 12 weeks after completion of SOC 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. 9. 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). 10. Eastern Cooperative Oncology Group (ECOG) performance status =1. 11. Females must b
Exclusion criteria
Exclusion criteria: Exclusion criteria: Patients are excluded if they meet any of the following exclusion criteria: 1. Local recurrence of or previous history of any ipsilateral or contralateral invasivebreast cancer within 10 years prior to randomization [for synchronous tumors seeExclusion Criteria #3]. 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 post-operative immunotherapy with antigen, antibody, immunecheckpoint inhibitors (Programmed cell death-1 [PD-1]/ Programmed cell deathligand-1 [PD-L-1] inhibitors, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4] therapy), or other anti-cancer vaccines (neoadjuvant receipt of immunecheckpoint inhibitors will not be exclusionary if the patient meets all other eligibilitycriteria). 5. Concomitant treatment with approved anticancer therapy or immunotherapy includingcheckpoint inhibitors (e.g. PD-1 inhibitors), or other investigational therapy, if expected during the study. Adjuvant capecitabine or platinum monotherapy isallowed during the study. 6. A history of other malignancies (except non-melanoma skin carcinoma, carcinomain situ of the uterine cervix, follicular or papillary thyroid cancer) within 5 years priorto randomization. 7. Have any active autoimmune disease or disorder that requires systemicimmunosuppressive/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. 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. 9. Any known uncontrolled concurrent illness that would limit compliance with studyrequirements, including but not limited to ongoing or active infections, symptomaticcongestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorders, or substance abuse. 10. Any known hypersensitivity to active/inactive ingredients in the study drugformulation or known severe allergy or anaphylaxis to fusion proteins. 11. Prior receipt of a glycoconjugate vaccine for cancer immunotherapy. 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). 13. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior torandomization. Patients who have completed curative therapy for HCV are eligible. For patients with evidence of chronic HBV infection, the HBV viral load must beundetectable on suppressive therapy. (Note: HBV/HCV testing is not required forstudy entry). 14. Any condition, including significant diseases and/or laboratory abnormalities thatwould place the patient at unacceptable risk for study participation. 15. Currently pregnant or breastfeeding women. 16. Currently participating in or has participated in a breast cancer therapeutic clinicaltrial within 4 weeks (28 days) prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from the date of randomization to the date of first invasive disease recurrence (local, regional, or distant),;The date of the second primary invasive cancer (breast or not), or;The date of death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS status;Change from baseline in health-related quality of life (HRQOL) using the global health status/QoL scale from EORTC QLQ-C30 and EQ-5D-5L questionnaires;Breast cancer-free interval (BCFI);Distant disease-free survival (DDFS);Incidence of AEs and SAEs, incidence of abnormal laboratory values, and change from baseline in safety parameters. | — |
Countries
Korea, Republic of
Contacts
Public ContactSuee Lee
Dong-A University
Outcome results
None listed