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NCT Number: 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

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.

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Key information

Conditions

Stomach Neoplasms Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BVAC-B

Biological

Autologous B cell and monocyte presenting HER2/neu antigen

Primary outcomes

  1. Evaluate Maximum tolerated dose(MTD) for phase 2 trial

    Time frame: End of Dose-escalation stage(7 month from study start, Estimated)

    Find Serious adverse drug reaction(Grade 3)

  2. Incidence of Serious Adverse Events assessed with CTCAE v4.03

    Time frame: 14th week from first injection

    Evaluate safety and tolerability

Secondary outcomes

  1. Serum cytokine

    Time frame: 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 Interferon(IFN)-r, Interleukin(IL)-4

  2. HER2/neu specific antibody

    Time frame: Screening visit, every 2 weeks after 1st injection(till 16th week)

    Measure HER2/neu specific antibody concentration

  3. NKT/NK cell assay

    Time frame: Screening visit, every 24hr after injection(up to 12th week)

    Measure NKT/NK cell activity

  4. CD4/CD8 assay

    Time frame: Screening visit, every 2 weeks after 1st injection(up to 16th week)

    Measure CD4/CD8 T cell activity

  5. Lymphocyte subset

    Time frame: Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)

    Measure change of lymphocyte subset

  6. Change of tumor burden

    Time frame: Screening visit, Termination visit(16th week)

    Measure change of tumor burden by CT/MRI to determine pre-effecacy

Sponsors and collaborators

Lead sponsor

Cellid Co., Ltd.

Industry

Registry information

Official study 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

Acronym: BVAC-B

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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