Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase III, Randomized, Double-blind, Placebo Controlled Study of Adagloxad Simolenin (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

Keywords

Triple Negative Breast Cancer Neoadjuvant chemotherapy Adjuvant chemotherapy TNBC Breast Neoplasms Triple Negative Breast Neoplasms adagloxad simolenin combined with OBI-821 Phosphate-buffered saline (PBS) Adagloxad simolenin + OBI-821

Eligibility

You can join if…

Open to people ages 18 years and up

  • Documented radiographic and histopathologic confirmed primary localized invasive breast cancer.
  • 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.
  • 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
  • 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. Instructions for submission of slides/tumor tissues block and pertinent reports to central review are provided in the study Lab Manual.
  • No evidence of metastatic disease in chest, abdomen and pelvis by CT or MRI scan during the Screening Phase. Historical report 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 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% 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
  • Must 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.

  • Surgery for treatment of primary cancer must be completed at least 2 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.
  • All adjuvant chemotherapy and/or radiotherapy (if indicated) after surgery, must have been completed at least 2 weeks prior to randomization.
  • 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 study treatment period and for at least 4 weeks after the last dose of study treatment.
  • 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)
  • 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.
  • Ability to understand and willingness to complete all protocol required procedures.

You CAN'T join if...

  • Local recurrence of or previous history of contralateral invasive breast cancer within 10 years of the current diagnosis.
  • Definitive clinical or radiologic evidence of metastatic disease
  • 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 4 weeks prior to randomization.
  • For patients undergoing neoadjuvant chemotherapy, more than one line of chemotherapy following surgery.
  • 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.
  • 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.
  • Receipt of any live, attenuated vaccine (including influenza vaccine, e.g., FluMist)within 4 weeks prior to randomization and during the study till 4 weeks after the last dose of study treatment. NOTE: inactivated vaccines (e.g., inactivated influenza vaccines) are allowed during the study, if required.
  • Prior receipt of a glycoconjugate vaccine for cancer immunotherapy; or has received glycoconjugate vaccine for bacterial infections within 4 weeks prior to randomization.
  • Known history or positive for human immunodeficiency virus (HIV positive)
  • 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.
  • Any condition, including significant diseases and/or laboratory abnormalities that would place the subject at unacceptable risk for study participation.
  • Currently pregnant or breastfeeding women.
  • Currently participating in a clinical study, and receiving an investigational drug or has participated in a therapeutic clinical trial within 4 weeks prior to randomization.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Centre not yet accepting patients
    San Francisco California 94158 United States
  • Long Beach Memorial Medical Center not yet accepting patients
    Long Beach California 90806 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
OBI Pharma, Inc
ID
NCT03562637
Phase
Phase 3
Study Type
Interventional
Last Updated