Clinical trial NCT03425773: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stomach Neoplasms
Keywords: HER2/neu
IHC 1+
BVAC
Cellid
B-cell
Monocyte
Immunotherapeutic vaccine
Breast cancer
Colorectal cancer
Pancreatic cancer
Lead sponsor: Cellid Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Accelerated titration
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluate Maximum tolerated dose(MTD) for phase 2 trial
timeFrame: End of Dose-escalation stage(7 month from study start, Estimated)
measure: Incidence of Serious Adverse Events assessed with CTCAE v4.03
timeFrame: 14th week from first injection
Secondary outcomes:
measure: Serum cytokine
timeFrame: 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: HER2/neu specific antibody
timeFrame: Screening visit, every 2 weeks after 1st injection(till 16th week)
measure: NKT/NK cell assay
timeFrame: Screening visit, every 24hr after injection(up to 12th week)
measure: CD4/CD8 assay
timeFrame: Screening visit, every 2 weeks after 1st injection(up to 16th week)
measure: Lymphocyte subset
timeFrame: Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)
measure: Change of tumor burden
timeFrame: Screening visit, Termination visit(16th week)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
References: