Solid TumorPhase 1NCT02289196
Safety Study of Vx006 Vaccine in Solid Tumor Patients
A Phase 1 study testing Vx-006: 0,5mg, Vx-006: 1mg and Vx-006: 5mg in people with Solid Tumor, run by Vaxon Biotech at 3 sites in Greece.
Trial summary
Patients with histologically proven malignancy with documented disease control (objective response or stable disease) or Not Evaluable Disease (NED) expectancy > 6 months; only HLA-A*02 positive patients. The primary objective of the trial is to compare safety and tolerability of four different doses of Vx-006. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Vx-006: 0,5mg, Vx-006: 1mg and Vx-006: 5mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesGreece
- Study dates
- Mar 2014to May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > or = 18 years of age;
- Histologically proven malignancy;
- Documented HLA-A*02 positivity, as determined by a central laboratory;
- Disease control (Complete Response (CR), Partial Response (PR), or Stable Disease (SD)) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria or NED in the case of patients who received adjuvant chemotherapy
- Patient with disease control or NED expectancy > or = 6 months according to investigator opinion;
- ECOG performance status 0, 1;
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- Patients must have adequate renal and hepatic function as assessed by standard laboratory criteria;
- Patients must have adequate haematological function:
- Platelet count > or = 100 x 109/L;
- White Blood Cell (WBC) count > or = 2.5 x 109/L;
- Haemoglobin > or = 90g /L;
- Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential must have a negative urine pregnancy test at baseline and agree to practice adequate contraception for 30 days prior to administration of investigational product, throughout the study treatment period and 30 days after completion of injections;
- In the investigator's opinion, the patient is capable and willing to comply with the requirements of the study;
- Willing and able to sign a written informed consent.
Who cannot join
- Prior treatment with cancer vaccines;
- Treatment with immunotherapy (e.g., interferons, interleukins, Tumor Necrosis Factor (TNF), or biological response modifiers, such as Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) etc) within four weeks prior to the first vaccination;
- Treatment with immunosuppressive agents (including corticosteroids) within 2 weeks prior to the first vaccination;
- Treatment with any investigational drugs, within 4 weeks prior to the first vaccination;
- Autoimmune or immunodeficiency disease that in the opinion of the investigator may compromise the safety of the patient in the study;
- Any pre-existing medical condition requiring concomitant systemic corticosteroid or immunosuppressive therapy. The use of inhaled corticosteroids for Chronic Obstructive Pulmonary Disease (COPD) or topical steroids is allowed;
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- Known hepatitis B and/or C infection documented in patient files, testing not required;
- Known HIV-positivity, testing not required;
- Clinically significant hepatic dysfunction (Alanine amino transferase (ALT)>2.5 times normal upper limits [ULN], Aspartate Amino Transferase (AST)>2.5 times Upper Limit of Normal (ULN), bilirubin>1.5 times ULN);
- Clinically significant renal dysfunction (serum creatinine>1.5 time ULN);
- Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months before enrolment) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable);
- Splenectomy or splenic irradiation;
- Any infectious condition that, in the opinion of the investigator, could compromise the patient's ability to develop an immune response;
- Pregnant or lactating females (female patients of child-bearing potential will undertake pregnancy testing at screening and during study completion/withdrawal visits);
- Alcohol or drug dependence;
- Requirement of concurrent treatment with prohibited medication (investigational product, other anti-cancer treatments including chemotherapy, non-palliative radiotherapy, biological agents and immunomodulating agents, systemic immunosuppressive agents, including systemic corticosteroids);
- The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
251 General Airforce Hospital
Athens, 11525
Iaso General Hospital
Athens, 15562
University General Hospital of Heraklion
Heraklion, Crete, 71110
About this study
Official title: A Multicenter, Open Label, Uncontrolled Phase I Trial to Compare Safety, Tolerability and Immunogenicity of Vx-006 Vaccine at 0.5mg, 1mg, 5mg and 10mg Doses in Human Leukocyte Antigen-A02 (HLA-A02) Positive Patients With Solid Tumours
Patients with histologically proven malignancy with documented disease control (objective response or stable disease) or Not Evaluable Disease (NED) expectancy > 6 months; only HLA-A*02 positive patients.
The primary objective of the trial is to compare safety and tolerability of four different doses of Vx-006. The secondary objective is to compare immunogenicity of four different doses of the Vx-006.
- Conditions
- Solid Tumor
- Being tested
- Vx-006: 0,5mg, Vx-006: 1mg, Vx-006: 5mg, Vx-006: 10mg
- Keywords
- Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vx-006: 0,5mgDrug
Vx-006: 1mgDrug
Vx-006: 5mgDrug
Vx-006: 10mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Vx-006: 0,5mg | Experimental | Six injections of Vx-006 at 0,5 mg + Montanide ISA51™ will be administrated every 3 weeks Receives: Drug: Vx-006: 0,5mg |
| Vx-006: 1mg | Experimental | Six injections of Vx-006 at 1 mg + Montanide ISA51™ will be administrated every 3 weeks Receives: Drug: Vx-006: 1mg |
| Vx-006: 5mg | Experimental | Six injections of Vx-006 at 5 mg + Montanide ISA51™ will be administrated every 3 weeks Receives: Drug: Vx-006: 5mg |
| Vx-006: 10mg | Experimental | Six injections of Vx-006 at 10 mg + Montanide ISA51™ will be administrated every 3 weeks Receives: Drug: Vx-006: 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event number by treatment group as a measure of safety and tolerability
The following parameters of safety and tolerability will be assessed:
- Physical examination and vital signs (blood pressure, pulse rate, body temperature, weight, height (only at baseline),
- Electrocardiogram,
- Adverse event evaluation,
- Eastern Cooperative Oncology Group (ECOG) performance status,
- Clinical laboratory evaluation: haematology and clinical chemistry
- Collection of concomitant medication
Measured: 18 Weeks
Secondary outcomes (1)
Immune response evaluation by treatment group as a measure of efficacy
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxon Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsaounis Panagiotis, MD, PhD, Principal investigator, Iaso General Hospital, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289196
- Sponsor's protocol ID
- Vx-006-101
- Status last verified
- Jun 2019
- First submitted
- 30 Oct 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Uncontrolled Phase I Trial to Compare Safety, Tolerability and Immunogenicity of Vx-006 Vaccine at 0.5mg, 1mg, 5mg and 10mg Doses in Human Leukocyte Antigen-A02 (HLA-A02) Positive Patients With Solid Tumours
- ClinicalTrials.gov ID
- NCT02289196
- Acronym / sponsor ID
- Vx-006-101
- Conditions
- Solid Tumor
- Keywords
- Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vaxon BiotechIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Nov 2014 (estimated)
- 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.
Patients with histologically proven malignancy with documented disease control (objective response or stable disease) or Not Evaluable Disease (NED) expectancy > 6 months; only HLA-A*02 positive patients.
The primary objective of the trial is to compare safety and tolerability of four different doses of Vx-006. The secondary objective is to compare immunogenicity of four different doses of the Vx-006.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vx-006: 0,5mg | Experimental | Drug: Vx-006: 0,5mgSix injections of Vx-006 at 0,5 mg + Montanide ISA51™ will be administrated every 3 weeks |
| Vx-006: 1mg | Experimental | Drug: Vx-006: 1mgSix injections of Vx-006 at 1 mg + Montanide ISA51™ will be administrated every 3 weeks |
| Vx-006: 5mg | Experimental | Drug: Vx-006: 5mgSix injections of Vx-006 at 5 mg + Montanide ISA51™ will be administrated every 3 weeks |
| Vx-006: 10mg | Experimental | Drug: Vx-006: 10mgSix injections of Vx-006 at 10 mg + Montanide ISA51™ will be administrated every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female > or = 18 years of age;
- Histologically proven malignancy;
- Documented HLA-A*02 positivity, as determined by a central laboratory;
- Disease control (Complete Response (CR), Partial Response (PR), or Stable Disease (SD)) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria or NED in the case of patients who received adjuvant chemotherapy
- Patient with disease control or NED expectancy > or = 6 months according to investigator opinion;
Key exclusion criteria (17 listed)
- Prior treatment with cancer vaccines;
- Treatment with immunotherapy (e.g., interferons, interleukins, Tumor Necrosis Factor (TNF), or biological response modifiers, such as Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) etc) within four weeks prior to the first vaccination;
- Treatment with immunosuppressive agents (including corticosteroids) within 2 weeks prior to the first vaccination;
- Treatment with any investigational drugs, within 4 weeks prior to the first vaccination;
- Autoimmune or immunodeficiency disease that in the opinion of the investigator may compromise the safety of the patient in the study;
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 |
|---|---|---|
| Vx-006: 0,5mg | Drug | Vx-006: 0,5mg |
| Vx-006: 1mg | Drug | Vx-006: 1mg |
| Vx-006: 5mg | Drug | Vx-006: 5mg |
| Vx-006: 10mg | Drug | Vx-006: 10mg |
Primary outcome
Adverse event number by treatment group as a measure of safety and tolerability
Time frame: 18 Weeks
The following parameters of safety and tolerability will be assessed: * Physical examination and vital signs (blood pressure, pulse rate, body temperature, weight, height (only at baseline), * Electrocardiogram, * Adverse event evaluation, * Eastern Cooperative Oncology Group (ECOG) performance status, * Clinical laboratory evaluation: haematology and clinical chemistry * Collection of concomitant medication
1 secondary outcome
Immune response evaluation by treatment group as a measure of efficacy
Time frame: 18 weeks
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 19 Jun 2019.
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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.
Katsaounis Panagiotis, MD, PhD principal investigator
Iaso General Hospital, Athens
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vx-006: 0,5mg, Vx-006: 1mg and Vx-006: 5mg in people with Solid Tumor, run by Vaxon Biotech at 3 sites in Greece.
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 14 inclusion and 17 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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?
Adverse event number by treatment group as a measure of safety and tolerability (time frame: 18 Weeks). 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 19 Jun 2019.