Clinical trial · Interventional
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
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
NCT03425773CI-TRIAL-00043541BVAC-BcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BVAC-B | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BVAC-B
- description
- BVAC-B IV injection at 0, 4, 8, 12nd weeks.
- interventionNames
- Biological: BVAC-B
Primary outcomes (2)
- measure
- Evaluate Maximum tolerated dose(MTD) for phase 2 trial
- timeFrame
- End of Dose-escalation stage(7 month from study start, Estimated)
- description
- Find Serious adverse drug reaction(Grade 3)
- measure
- Incidence of Serious Adverse Events assessed with CTCAE v4.03
- timeFrame
- 14th week from first injection
- description
- Evaluate safety and tolerability
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.