Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Gro… (NCT03425773) | Clinical Trial Compass
CompletedPhase 1
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
South Korea8 participantsStarted 2018-02-26
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 radiati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate Maximum tolerated dose(MTD) for phase 2 trial
Timeframe: End of Dose-escalation stage(7 month from study start, Estimated)
2
Incidence of Serious Adverse Events assessed with CTCAE v4.03