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OBI-822-011: A phase III, randomized, double-blind, placebo-controlled study of adagloxad simolehin (OBI 822)/OBI 821 treatment for high-risk, early-stage, triple-negative breast cancer patients, defined as residual invasive disease following neoadjuvant chemotherapy or ≥4 positive axillary nodes

Description

This is a phase III, randomized, double-blind, placebo controlled, study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 treatment, compared to placebo, in patients with early stage TNBC at high risk for recurrence.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to measure the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improving invasive disease free survival (IDFS) in the study population.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have documented radiographic and histopathologic confirmed primary localized invasive breast cancer
  • Have 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
  • Have 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
  • Have 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 (Note: Instructions for submission of slides/tumor tissues block and pertinent reports to central review are provided in the study lab manual.)
  • Have no evidence of metastatic disease in chest, abdomen and pelvis by CT or MRI scan during the Screening Phase (Historical report within three 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.)
  • Are 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 percent 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
  • Have completed taxane (with or without platinum), and/or anthracycline-based chemotherapy (either sequential or concurrent) either in the neoadjuvant or adjuvant setting (Post-neoadjuvant chemotherapy with capecitabine or a platinum salt is allowed.)
  • Had surgery for treatment of primary cancer completed at least two 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
  • Have 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)
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • If female, must be either of non-childbearing potential, i.e., surgically sterilized (have documented sterilization, bilateral oophorectomy/salpingectomy at least three 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
  • Must be willing to use effective contraception during the entire study treatment period and for at least four weeks after the last dose of study treatment
  • Have 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)
  • Have left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
  • Consent to participate with a signed and dated IRB-approved patient informed consent for the study prior to beginning any specific study procedures.
  • Are able to understand and willingness to complete all protocol required procedures.

Excluding patients who:

  • Had local recurrence of or previous history of contralateral invasive breast cancer within 10 years of the current diagnosis.
  • Have definitive clinical or radiologic evidence of metastatic disease
  • Have synchronous bilateral breast cancer, unless both tumors are confirmed as TNBC
  • Have received 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 four weeks prior to randomization
  • Are undergoing neoadjuvant chemotherapy, more than one line of chemotherapy following surgery.
  • Have 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
  • 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.)
  • Have oral/parenteral corticosteroid treatment (>5 mg/day of prednisone/equivalent), within two weeks prior to randomization or anytime during the study. (Note: Inhaled steroids for treatment of asthma; and topical steroids are allowed during the study.)
  • Have 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
  • Ave any known hypersensitivity to active/inactive ingredients in the study drug formulation or known severe allergy or anaphylaxis to fusion proteins
  • Have received any live, attenuated vaccine (including influenza vaccine, e.g., FluMist) within four weeks prior to randomization and during the study until four weeks after the last dose of study treatment (Note: inactivated vaccines, such as inactivated influenza vaccines, are allowed during the study, if required.)
  • Received a glycoconjugate vaccine for cancer immunotherapy; or has received glycoconjugate vaccine for bacterial infections within 4 weeks prior to randomization
  • Have a known history or positive for human immunodeficiency virus (HIV positive)
  • Show 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
  • Have any condition, including significant diseases and/or laboratory abnormalities that would place the subject at unacceptable risk for study participation
  • Are pregnant or breastfeeding
  • Are participating in a clinical study, and receiving an investigational drug or has participated in a therapeutic clinical trial within four weeks prior to randomization
     

Accepting new patients

 

Learn more at

clinicaltrials.gov