Stomach Neoplasms
Conditions
Keywords
HER2/neu, IHC 1+, BVAC, Cellid, B-cell, Monocyte, Immunotherapeutic vaccine, Breast cancer, Colorectal cancer, Pancreatic cancer
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.
Interventions
BIOLOGICALBVAC-B
Autologous B cell and monocyte presenting HER2/neu antigen
Sponsors
Cellid Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Accelerated titration
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Maximum tolerated dose(MTD) for phase 2 trial | End of Dose-escalation stage(7 month from study start, Estimated) | Find Serious adverse drug reaction(Grade 3) |
| Incidence of Serious Adverse Events assessed with CTCAE v4.03 | 14th week from first injection | Evaluate safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NKT/NK cell assay | Screening visit, every 24hr after injection(up to 12th week) | Measure NKT/NK cell activity |
| CD4/CD8 assay | Screening visit, every 2 weeks after 1st injection(up to 16th week) | Measure CD4/CD8 T cell activity |
| Serum cytokine | 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) | Measure Interferon(IFN)-r, Interleukin(IL)-4 |
| Change of tumor burden | Screening visit, Termination visit(16th week) | Measure change of tumor burden by CT/MRI to determine pre-effecacy |
| Lymphocyte subset | Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week) | Measure change of lymphocyte subset |
| HER2/neu specific antibody | Screening visit, every 2 weeks after 1st injection(till 16th week) | Measure HER2/neu specific antibody concentration |
Countries
South Korea
Outcome results
None listed