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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| BVAC-B | | BVAC-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
| Name | Type | Description | Interventions |
|---|
| BVAC-B | Experimental | BVAC-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: | Completed |
| Lead Sponsor: | Cellid Co., Ltd. |
Trial Keywords
- HER2/neu
- IHC 1+
- BVAC
- Cellid
- B-cell
- Monocyte
- Immunotherapeutic vaccine
- Breast cancer
- Colorectal cancer
- Pancreatic cancer
Last Updated
February 20, 2020
