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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vx-006: 0,5mg | Experimental | Six injections of Vx-006 at 0,5 mg + Montanide ISA51â„¢ will be administrated every 3 weeks |
|
| Vx-006: 1mg | Experimental | Six injections of Vx-006 at 1 mg + Montanide ISA51â„¢ will be administrated every 3 weeks |
|
| Vx-006: 5mg | Experimental | Six injections of Vx-006 at 5 mg + Montanide ISA51â„¢ will be administrated every 3 weeks |
|
| Vx-006: 10mg | Experimental | Six injections of Vx-006 at 10 mg + Montanide ISA51â„¢ will be administrated every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vx-006: 0,5mg | Drug |
| ||
| Vx-006: 1mg |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event number by treatment group as a measure of safety and tolerability | The following parameters of safety and tolerability will be assessed:
| 18 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response evaluation by treatment group as a measure of efficacy | 18 weeks |
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Inclusion Criteria:
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;
Patients must have adequate renal and hepatic function as assessed by standard laboratory criteria;
Patients must have adequate haematological function:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsaounis Panagiotis, MD, PhD | Iaso General Hospital, Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 251 General Airforce Hospital | Athens | 11525 | Greece | |||
| Iaso General Hospital |
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| Vx-006: 5mg | Drug |
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| Vx-006: 10mg | Drug |
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| Athens |
| 15562 |
| Greece |
| University General Hospital of Heraklion | Heraklion, Crete | 71110 | Greece |