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 (BVAC-B)

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

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.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Biological: BVAC-B

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 03722
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BVAC-B; BVAC-B IV injection at 0, 4, 8, 12nd weeks.	Biological: BVAC-B; Autologous B cell and monocyte presenting HER2/neu antigen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Incidence of Serious Adverse Events assessed with CTCAE v4.03	Evaluate safety and tolerability	14th week from first injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
HER2/neu specific antibody	Measure HER2/neu specific antibody concentration	Screening visit, every 2 weeks after 1st injection(till 16th week)
NKT/NK cell assay	Measure NKT/NK cell activity	Screening visit, every 24hr after injection(up to 12th week)
CD4/CD8 assay	Measure CD4/CD8 T cell activity	Screening visit, every 2 weeks after 1st injection(up to 16th week)
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)
Change of tumor burden	Measure change of tumor burden by CT/MRI to determine pre-effecacy	Screening visit, Termination visit(16th week)

Collaborators and Investigators

• Sponsor: Cellid Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2018
• Primary Completion (ACTUAL): May 13, 2019
• Study Completion (ACTUAL): May 13, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Colorectal cancer; Breast cancer; Pancreatic cancer; B-cell; Monocyte; Immunotherapeutic vaccine; HER2/neu; IHC 1+; BVAC; Cellid
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: BVAC-B-P1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No