Trials / Completed
CompletedNCT03425773
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Cellid Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BVAC-B | Autologous B cell and monocyte presenting HER2/neu antigen |
Timeline
- Start date
- 2018-02-26
- Primary completion
- 2019-05-13
- Completion
- 2019-05-13
- First posted
- 2018-02-08
- Last updated
- 2020-02-20
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03425773. Inclusion in this directory is not an endorsement.