Status:
COMPLETED
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
Lead Sponsor:
Cellid Co., Ltd.
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03425773
Start Date
February 26 2018
End Date
May 13 2019
Last Update
February 20 2020
Active Locations (1)
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1
Severance Hospital
Seoul, Seodaemun-gu, South Korea, 03722