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
Phase 1
Completed
- Conditions
- Stomach Neoplasms
- Interventions
- Biological: BVAC-B
- Registration Number
- NCT03425773
- Lead Sponsor
- Cellid Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BVAC-B BVAC-B BVAC-B IV injection at 0, 4, 8, 12nd weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
HER2/neu specific antibody Screening visit, every 2 weeks after 1st injection(till 16th week) Measure HER2/neu specific antibody concentration
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
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
Change of tumor burden Screening visit, Termination visit(16th week) Measure change of tumor burden by CT/MRI to determine pre-effecacy
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Seodaemun-gu, Korea, Republic of