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

Cellid

Status and phase

Completed

Phase 1

Conditions

Stomach Neoplasms

Treatments

Biological: BVAC-B

Study type

Interventional

Funder types

Industry

Identifiers

NCT03425773

BVAC-B-P1

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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