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

Stomach Neoplasms Clinical Trial

— BVAC-B  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425773
• Other study ID #: BVAC-B-P1
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2018
• Est. completion date: May 13, 2019

Study information

• Verified date: February 2020
• Source: Cellid Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 13, 2019
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Biological:
• BVAC-B
Autologous B cell and monocyte presenting HER2/neu antigen

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Cellid Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Maximum tolerated dose(MTD) for phase 2 trial	Find Serious adverse drug reaction(Grade 3)	End of Dose-escalation stage(7 month from study start, Estimated)
Primary	Incidence of Serious Adverse Events assessed with CTCAE v4.03	Evaluate safety and tolerability	14th week from first injection
Secondary	Serum cytokine	Measure Interferon(IFN)-r, Interleukin(IL)-4	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)
Secondary	HER2/neu specific antibody	Measure HER2/neu specific antibody concentration	Screening visit, every 2 weeks after 1st injection(till 16th week)
Secondary	NKT/NK cell assay	Measure NKT/NK cell activity	Screening visit, every 24hr after injection(up to 12th week)
Secondary	CD4/CD8 assay	Measure CD4/CD8 T cell activity	Screening visit, every 2 weeks after 1st injection(up to 16th week)
Secondary	Lymphocyte subset	Measure change of lymphocyte subset	Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)
Secondary	Change of tumor burden	Measure change of tumor burden by CT/MRI to determine pre-effecacy	Screening visit, Termination visit(16th week)