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

Study Overview

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

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.

N/A

Stomach Neoplasms

BIOLOGICAL: BVAC-B

BVAC-B-P1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-01-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-02-19
First Submitted that Met QC Criteria 2018-02-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-02-20
First Posted (ACTUAL) 2018-02-08	Results First Posted N/A	Last Verified 2020-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BVAC-B BVAC-B IV injection at 0, 4, 8, 12nd weeks.	BIOLOGICAL: BVAC-B Autologous B cell and monocyte presenting HER2/neu antigen

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: BVAC-B

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

BIOLOGICAL: BVAC-B

Autologous B cell and monocyte presenting HER2/neu antigen

Primary Outcome Measures	Measure Description	Time Frame
Evaluate Maximum tolerated dose(MTD) for phase 2 trial	Find Serious adverse drug reaction(Grade 3)	End of Dose-escalation stage(7 month from study start, Estimated)
Incidence of Serious Adverse Events assessed with CTCAE v4.03	Evaluate safety and tolerability	14th week from first injection

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record