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Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care

NCT03425773

Description:

BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.

Related Conditions:
  • Gastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care
  • Official Title: Single Center, Open-label, Accelerated Titration, Multiple Dosing Study to Evaluate the Safety, Tolerability, Immune Response and Pre-efficacy of BVAC-B in Patients With Progressive or Recurrent HER2/Neu Positive Gastric Cancer After Failure to Standard Care

Clinical Trial IDs

  • ORG STUDY ID: BVAC-B-P1
  • NCT ID: NCT03425773

Conditions

  • Stomach Neoplasms

Interventions

DrugSynonymsArms
BVAC-BBVAC-B

Purpose

BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.

Trial Arms

NameTypeDescriptionInterventions
BVAC-BExperimentalBVAC-B IV injection at 0, 4, 8, 12nd weeks.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Progressive or recurrent HER2/neu positive(IHC 1+≥) gastric cancer
    
              -  Received 1 or more chemotherapy or radiotherapy as prior therapy for progressive or
                 recurrent tumor lesion
    
              -  At least 1 measurable lesion according to RECIST(ver 1.1)
    
              -  Ages above 19
    
              -  ECOG performance status between 0 to 2
    
              -  Patients meets the blood test standards in the screening test
    
              -  Patients meets the blood chemistry test standards in the screening test
    
              -  Patients who has agreed to a medically accepted contraceptive in this clinical trial
    
              -  Patients at least six months or more of survival can be expected
    
              -  Patients decided to participate in this clinical trial and signed written informed
                 consent
    
            Exclusion Criteria:
    
              -  Histopathology is a neuroendocrine or small cell carcinoma
    
              -  History of brain metastasis or signs of brain metastasis
    
              -  Clinical diagnosis of hepatitis C or hepatitis B
    
              -  Clinical diagnosis of human immunodeficiency virus (HIV)
    
              -  History of HIV infection
    
              -  Patients with heart failure, coronary artery disease(CAD) or Myocardial infarction in
                 6 month prior to screening. (LVEF is lower than 50% in screening visit)
    
              -  Administered the drug for other clinical trials within 4weeks before participate in
                 this trial
    
              -  Administered any vaccines within 4weeks before participate in this trial (4 weeks for
                 live vaccine, 2 weeks for other inactivated vaccine)
    
              -  Administered the granulocytes concentrates within 3 months before the screening visit
    
              -  Received chemotherapy or radiation therapy within 2 weeks before the 1st
                 administration of investigational drug(BVAC-B)
    
              -  Received following formulation within 1 months before the screening visit : Chronic
                 steroids(more than 5 days), immunosuppressant or immunomodulatory agents. G-CSF
    
              -  Patients who have participated in the clinical trial of a immunotherapeutic vaccine
                 within 1 year or immunotherapy within 3 months before the screening visit
    
              -  Patients who is pregnant or breast-feeding
    
              -  Patients who researchers has determined that participation in the clinical trial is
                 inappropriate
    
              -  Suspected to have other progressive cancer or malignant tumor needs treatment in 3
                 years. Completely treated basal cell carcinoma of the skin, squamous cell carcinoma of
                 the skin, thyroid carcinoma, cervical intraepithelial neoplasia are not included
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:19 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Evaluate Maximum tolerated dose(MTD) for phase 2 trial
    Time Frame:End of Dose-escalation stage(7 month from study start, Estimated)
    Safety Issue:
    Description:Find Serious adverse drug reaction(Grade 3)

    Secondary Outcome Measures

    Measure:Serum cytokine
    Time Frame:Screening visit, Visit 2 (0 week) , visit 4 (4 week) ,visit 5 (6 week), visit 6 (8 week), visit 8(12 week), Termination visit(16 week)
    Safety Issue:
    Description:Measure Interferon(IFN)-r, Interleukin(IL)-4
    Measure:HER2/neu specific antibody
    Time Frame:Screening visit, every 2 weeks after 1st injection(till 16th week)
    Safety Issue:
    Description:Measure HER2/neu specific antibody concentration
    Measure:NKT/NK cell assay
    Time Frame:Screening visit, every 24hr after injection(up to 12th week)
    Safety Issue:
    Description:Measure NKT/NK cell activity
    Measure:CD4/CD8 assay
    Time Frame:Screening visit, every 2 weeks after 1st injection(up to 16th week)
    Safety Issue:
    Description:Measure CD4/CD8 T cell activity
    Measure:Lymphocyte subset
    Time Frame:Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)
    Safety Issue:
    Description:Measure change of lymphocyte subset
    Measure:Change of tumor burden
    Time Frame:Screening visit, Termination visit(16th week)
    Safety Issue:
    Description:Measure change of tumor burden by CT/MRI to determine pre-effecacy

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Cellid Co., Ltd.

    Trial Keywords

    • HER2/neu
    • IHC 1+
    • BVAC
    • Cellid
    • B-cell
    • Monocyte
    • Immunotherapeutic vaccine
    • Breast cancer
    • Colorectal cancer
    • Pancreatic cancer

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