Stomach NeoplasmsPhase 1BVAC-BNCT03425773
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
A Phase 1 study testing BVAC-B in people with Stomach Neoplasms, run by Cellid Co., Ltd. at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- BVAC-B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2018to 13 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Stomach Neoplasms
- Being tested
- BVAC-B
- Keywords
- HER2/neu, IHC 1+, BVAC, Cellid, B-cell, Monocyte, Immunotherapeutic vaccine, Breast cancer, Colorectal cancer, Pancreatic cancer
- Medical subject headings
- Stomach Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVAC-BBiological
Autologous B cell and monocyte presenting HER2/neu antigen
| Study group | Role | What they receive |
|---|---|---|
| BVAC-B | Experimental | BVAC-B IV injection at 0, 4, 8, 12nd weeks. Receives: Biological: BVAC-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Maximum tolerated dose(MTD) for phase 2 trial
Find Serious adverse drug reaction(Grade 3)
Measured: 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
Measured: 14th week from first injection
Secondary outcomes (6)
Serum cytokine
Measure Interferon(IFN)-r, Interleukin(IL)-4
Measured: 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
Measured: Screening visit, every 2 weeks after 1st injection(till 16th week)
NKT/NK cell assay
Measure NKT/NK cell activity
Measured: Screening visit, every 24hr after injection(up to 12th week)
CD4/CD8 assay
Measure CD4/CD8 T cell activity
Measured: Screening visit, every 2 weeks after 1st injection(up to 16th week)
Lymphocyte subset
Measure change of lymphocyte subset
Measured: 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
Measured: Screening visit, Termination visit(16th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start26 Feb 2018
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Accelerated titration
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellid Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425773
- Sponsor's protocol ID
- BVAC-B-P1
- Acronym
- BVAC-B
- Status last verified
- Feb 2020
- First submitted
- 29 Jan 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03425773
- Acronym / sponsor ID
- BVAC-B / BVAC-B-P1
- Conditions
- Stomach Neoplasms
- Keywords
- HER2/neu, IHC 1+, BVAC, Cellid, B-cell, Monocyte, Immunotherapeutic vaccine, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cellid Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Accelerated titration
| Arm | Type | Receives |
|---|---|---|
| BVAC-B | Experimental | Biological: BVAC-BBVAC-B IV injection at 0, 4, 8, 12nd weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVAC-BAutologous B cell and monocyte presenting HER2/neu antigen | Biological | BVAC-B |
Primary outcome
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)
Incidence of Serious Adverse Events assessed with CTCAE v4.03
Time frame: 14th week from first injection
Evaluate safety and tolerability
6 secondary outcomes
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)
HER2/neu specific antibody
Time frame: Screening visit, every 2 weeks after 1st injection(till 16th week)
NKT/NK cell assay
Time frame: Screening visit, every 24hr after injection(up to 12th week)
CD4/CD8 assay
Time frame: Screening visit, every 2 weeks after 1st injection(up to 16th week)
Lymphocyte subset
Time frame: Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)
Change of tumor burden
Time frame: Screening visit, Termination visit(16th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BVAC-B in people with Stomach Neoplasms, run by Cellid Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Maximum tolerated dose(MTD) for phase 2 trial (time frame: End of Dose-escalation stage(7 month from study start, Estimated)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.