Back to resultsSafety 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)
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BVAC-B
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring HER2/neu, IHC 1+, BVAC, Cellid, B-cell, Monocyte, Immunotherapeutic vaccine, Breast cancer, Colorectal cancer, Pancreatic cancer
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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BVAC-B
Arm Description
BVAC-B IV injection at 0, 4, 8, 12nd weeks.
Outcomes
Primary Outcome Measures
Evaluate Maximum tolerated dose(MTD) for phase 2 trial
Find Serious adverse drug reaction(Grade 3)
Incidence of Serious Adverse Events assessed with CTCAE v4.03
Evaluate safety and tolerability
Secondary Outcome Measures
Serum cytokine
Measure Interferon(IFN)-r, Interleukin(IL)-4
HER2/neu specific antibody
Measure HER2/neu specific antibody concentration
NKT/NK cell assay
Measure NKT/NK cell activity
CD4/CD8 assay
Measure CD4/CD8 T cell activity
Lymphocyte subset
Measure change of lymphocyte subset
Change of tumor burden
Measure change of tumor burden by CT/MRI to determine pre-effecacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03425773
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
Acronym
BVAC-B
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
May 13, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellid Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
HER2/neu, IHC 1+, BVAC, Cellid, B-cell, Monocyte, Immunotherapeutic vaccine, Breast cancer, Colorectal cancer, Pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Accelerated titration
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BVAC-B
Arm Type
Experimental
Arm Description
BVAC-B IV injection at 0, 4, 8, 12nd weeks.
Intervention Type
Biological
Intervention Name(s)
BVAC-B
Intervention Description
Autologous B cell and monocyte presenting HER2/neu antigen
Primary Outcome Measure Information:
Title
Evaluate Maximum tolerated dose(MTD) for phase 2 trial
Description
Find Serious adverse drug reaction(Grade 3)
Time Frame
End of Dose-escalation stage(7 month from study start, Estimated)
Title
Incidence of Serious Adverse Events assessed with CTCAE v4.03
Description
Evaluate safety and tolerability
Time Frame
14th week from first injection
Secondary Outcome Measure Information:
Title
Serum cytokine
Description
Measure Interferon(IFN)-r, Interleukin(IL)-4
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)
Title
HER2/neu specific antibody
Description
Measure HER2/neu specific antibody concentration
Time Frame
Screening visit, every 2 weeks after 1st injection(till 16th week)
Title
NKT/NK cell assay
Description
Measure NKT/NK cell activity
Time Frame
Screening visit, every 24hr after injection(up to 12th week)
Title
CD4/CD8 assay
Description
Measure CD4/CD8 T cell activity
Time Frame
Screening visit, every 2 weeks after 1st injection(up to 16th week)
Title
Lymphocyte subset
Description
Measure change of lymphocyte subset
Time Frame
Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)
Title
Change of tumor burden
Description
Measure change of tumor burden by CT/MRI to determine pre-effecacy
Time Frame
Screening visit, Termination visit(16th week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs