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    Summary
    EudraCT Number:2022-000897-24
    Sponsor's Protocol Code Number:P-VCNA-003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-000897-24
    A.3Full title of the trial
    A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer
    Estudio aleatorizado, sin enmascaramiento de fase IIb de nabpaclitaxel y gemcitabina con y sin el virus VCN-01 en pacientes con cáncer de páncreas metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the impact of VCN-01 on the overall survival of patients with advanced pancreatic cancer treated with standard therapy.
    Estudio para evaluar el impacto de VCN-01 en la supervivencia global de pacientes con cáncer de páncreas avanzado tratados con la terapia estándar
    A.4.1Sponsor's protocol code numberP-VCNA-003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVCN Biosciences, S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVCN Biosciences, Synthetic Biologic’s European Subsidiary
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVCN Biosciences, S.L.
    B.5.2Functional name of contact pointManel Cascallo
    B.5.3 Address:
    B.5.3.1Street AddressAvinguda de la Generalitat, 152-158
    B.5.3.2Town/ citySant Cugat del Vallès (Barcelona)
    B.5.3.3Post code08174
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935712359
    B.5.5Fax number+34935712129
    B.5.6E-mailMCascallo@vcnbiosciences.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/COMP/309860/2011
    D.3 Description of the IMP
    D.3.1Product nameVCN-01
    D.3.2Product code VCN-01
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applicable
    D.3.9.2Current sponsor codeVCN-01
    D.3.9.3Other descriptive nameGenetically modified HAd5 encoding human PH20 hyaluronidase
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.44E12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Pancreatic Cancer
    Cancer de pancreas avanzado
    E.1.1.1Medical condition in easily understood language
    Advanced Cancer
    Cancer Avanzado.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives are:
    • To evaluate the time from randomization until death in both arms (OS).
    • To evaluate the safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm II.
    Objetivos primarios:
    •Evaluar el tiempo que transcurre desde la aleatorización hasta la muerte en los dos grupos (supervivencia global [SG]).
    •Evaluar la seguridad y la tolerabilidad del VCN-01, administrado por vía intravenosa (i.v.) en la semana 1 y la semana 14 en el grupo II.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To evaluate the time to progression (TTP) or PFS.
    • To determine the ORR.
    • To determine the disease control rate (DCR) (stable disease [SD] + PR + complete response [CR]).
    • To determine the landmark 1-year survival and PFS at the 1-year landmark.
    • To evaluate the duration of response (DoR).
    • To assess changes in tumor marker Ca 19.9 measured every 4 weeks while on study.
    Objetivos secundarios:
    •Evaluar el tiempo transcurrido hasta la progresión (TTP) o la supervivencia sin progresión (SSP).
    •Determinar la tasa de respuesta objetiva (TRO).
    •Determinar la tasa de control de la enfermedad (TCE) (enfermedad estable [EE] + respuesta parcial [RP] + respuesta completa [RC]).
    •Determinar la supervivencia y la SSP ambas con punto temporal de referencia de 1 año.
    •Evaluar la duración de la respuesta (DdR).
    •Evaluar los cambios en el marcador tumoral antígeno carbohidrato (Ca) 19.9 determinado cada 4 semanas mientras se continúe en el estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained prior to any study-specific procedures or assessments.
    2. Male/female patients aged 18 years or over.
    3. Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never received previous systemic treatment for their pancreatic cancer for which the established therapy is nab-paclitaxel/gemcitabine (clinical SoC). All patients must have at least one measurable tumor lesion that can be imaged for assessments determined by RECIST 1.1 (see APPENDIX 4).
    4. Patients willing to comply with the study treatment.
    5. Patients with a minimum life expectancy of 5 months.
    6. ECOG performance status of 0 or 1.
    7. Use of a reliable method of contraception in fertile men and women. Female patients of childbearing potential (i.e., female patients who are not postmenopausal or surgically sterile) must agree to use effective contraception. Male patients must agree to use effective contraception or be surgically sterile.
    8. Adequate baseline organ function (hematologic, liver, renal and nutritional) within 1 week of randomization:
    Hematology:
    • Absolute neutrophil count ≥1.5x109 /L
    • Hemoglobin ≥9 g/dL
    • Platelets ≥100x109/L
    Coagulation (*except in patients on anticoagulants):
    • Prothrombin time or international normalized ratio ≤1x upper limit of normal (ULN)
    • Activated partial thromboplastin time ≤1.2xULN
    Hepatic:
    • Total bilirubin ≤1.5xULN
    • ALT and AST ≤2.5xULN (if there are no liver metastases)
    • ALT and AST <5xULN, and bilirubin <1.5xULN (if there are liver
    metastases)
    Renal:
    • Serum creatinine ≤1.5xULN, and if >1.5xULN: Estimated creatinine
    clearance >50 mL/min using Cockcroft and Gault formula
    Nutritional:
    • Serum Albumin ≥30 g/L
    Note: If laboratory or imaging procedures were performed for alternate reasons prior to signing consent, these can be used for screening purposes with consent of the patient.
    1. Obtención del consentimiento informado por escrito, antes de realizar cualquier procedimiento o evaluación específica de estudio.
    2. Pacientes hombres y mujeres de 18 años o más.
    3. Pacientes en primera linea de adenocarcinoma de páncreas metastásico estadio IV de novo confirmado histológica o citológicamente que nunca hayan recibido tratamiento sistémico previo para su cáncer de páncreas por el cual la terapia establecida es nab-paclitaxel/gemcitabina (clínica SoC). Todos los pacientes deben tener al menos una lesión tumoral medible, de las que se puedan obtener imágenes para las evaluaciones determinadas por RECIST 1.1.
    4. Pacientes dispuestos a cumplir con el tratamiento del estudio.
    5. Pacientes con una expectativa de vida mínima de 5 meses.
    6. Estado de salud, ECOG de 0 o 1.
    7. Uso de un método anticonceptivo confiable en hombres y mujeres fértiles. Pacientes mujeres en edad fértil (es decir, pacientes mujeres no postmenopáusicas o estériles quirúrgicamente) deben estar de acuerdo en usar un método de anticoncepción. Los pacientes varones deben estar de acuerdo en usar métodos anticonceptivos efectivos o ser quirúrgicamente estéril.
    8. Función básica adecuada de los órganos (hematológicos, hepáticos, renales y nutricional) dentro de la 1ª semana de la aleatorización:
    Hematología:
    • Recuento absoluto de neutrófilos ≥1,5x109 /L
    • Hemoglobina ≥9 g/dL
    • Plaquetas ≥100x109/L
    Coagulación (*excepto en pacientes con anticoagulantes):
    • Tiempo de protrombina o índice internacional normalizado ≤1x límite superior de
    normales (LSN)
    • Tiempo de tromboplastina parcial activada ≤1,2xULN
    Hepático:
    • Bilirrubina total ≤1.5xULN
    • ALT y AST ≤2,5xULN (si no hay metástasis hepáticas)
    • ALT y AST <5xLSN y bilirrubina <1,5xLSN (si hay insuficiencia hepática). Metástasis)
    Renal:
    • Creatinina sérica ≤1,5xLSN. Y si >1,5xLSN: Aclaramiento estimado de creatinina >50 ml/min utilizando la fórmula de Cockcroft y Gault.
    Nutricional:
    • Albúmina sérica ≥30 g/L
    Nota: Si los procedimientos de laboratorio o de imágenes se realizaron por razones alternativas antes de firmar el consentimiento, estos pueden usarse con fines de detección con el consentimiento del paciente.
    E.4Principal exclusion criteria
    1. Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons.
    2. Active infection or other serious illness or autoimmune disease at the moment of randomization.
    3. Treatment with live attenuated vaccines in the last 3 weeks and with the adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of study treatment.
    4. Known chronic liver disease (liver cirrhosis, chronic hepatitis). If there is a suspect of hepatic fibrosis, a fibroscan must be performed; patients with a value ≥9.5 kPa will be excluded. Note: Transient elastography (Fibroscan) is a non-invasive method for the assessment of hepatic fibrosis.
    5. Treatment with another investigational agent within five of that treatment’s half-lives prior to infusion of study treatment.
    6. Viral syndrome diagnosed during the 2 weeks before start of study treatment administration.
    7. Chronic immunosuppressive therapy, except inhaled corticosteroids, and oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent/day (exception: dexamethasone 1 mg/day as maximum).
    8. Concurrent malignant hematologic or solid disease. Patients with a prior history of cancer can be allowed if complete remission for at least 3 years.
    9. Patients in close contact (e.g., living in same house) with immunosuppressed patients (i.e., patients with chronic immunosuppressive therapy including high dose of corticosteroids,
    patients with acquired immunodeficiency syndrome (AIDS), and other chronic immune system diseases).
    10. Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.
    11. A female patient, who is pregnant or lactating.
    12. Patients receiving full-dose anticoagulant therapy or in whom these therapies cannot be withdrawn 2 days prior and 2 days after VCN-01 administration. Patients with uncontrolled coagulopathy should be excluded.
    13. Untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage. Patients with brain metastases with stable symptoms can be included.
    14. Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection/inflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.
    15. Patients with previous pneumonitis or interstitial lung disease.
    16. Patients with pre-existing sensory neuropathy >G1.
    17. Patients with known risk factors for bowel perforation, i.e., history of diverticulitis, intraabdominal abscess, intestinal obstruction or abdominal carcinomatosis.
    18. Patients with QT interval corrected by Fridericia (QTcF) assessment >450 ms for men or >470 ms for women and left ventricular ejection fraction (LVEF) evaluation less than 50% measured by ECHO or multigated acquisition scan.
    1. Pacientes que no estén dispuestos a completar los procedimientos del estudio por razones geográficas, psiquiátricas o sociales.
    2. Infección activa u otra enfermedad grave o enfermedad autoinmune en el momento de la aleatorización.
    3. Tratamiento con vacunas vivas atenuadas en las últimas 3 semanas y con la vacuna COVID, basada en adenovirus tipo 5 (Ad5), en las últimas 12 semanas antes de la administración del tratamiento del estudio.
    4. Enfermedad hepática crónica conocida (cirrosis hepática, hepatitis crónica). Si hay sospecha de fibrosis hepática, se debe realizar un fibroscan; se excluirán los pacientes con un valor ≥ 9,5 kPa. Nota: La elastografía transitoria (Fibroscan) es un método no invasivo para la evaluación de fibrosis hepática.
    5. Tratamiento con otro producto en investigación en un periodo inferior a cinco vidas medias de dicho fármaco, previamente a la administración de VCN-01
    6. Síndrome viral diagnosticado durante las 2 semanas anteriores al inicio de la administración del tratamiento del estudio.
    7. Terapia inmunosupresora crónica, excepto corticoides inhalados y corticoides orales o intravenosos a dosis inferior a 10 mg de prednisona o equivalente/día (excepción: dexametasona 1 mg/día como máximo).
    8. Enfermedad hematológica o sólida maligna concurrente. Los pacientes con antecedentes de cáncer pueden ser admitidos si la remisión es completa durante al menos 3 años.
    9. Pacientes en estrecho contacto (p. ej., que viven en la misma casa) con pacientes inmunodeprimidos (es decir, pacientes con terapia inmunosupresora que incluye altas dosis de corticosteroides, pacientes con síndrome de inmunodeficiencia adquirida (SIDA) y otras enfermedades crónicas del sistema inmunitario).
    10. Pacientes con síndrome de Li Fraumeni o con deficiencia de la línea germinal en la vía de la proteína de la retinoblastoma previamente conocida.
    11. Paciente mujer, que esté embarazada o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    • OS
    • Safety and tolerability
    • OS
    • seguridad y tolerabilidad
    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study
    A lo largo del estudio
    E.5.2Secondary end point(s)
    • PFS or TTP
    • ORR
    • DCR (SD + PR + CR)
    • Landmark 1-year survival and PFS at the 1-year landmark
    • DoR
    • Changes in tumor marker Ca 19.9
    • PFS or TTP
    • ORR
    • DCR (SD + PR + CR)
    • Punto de referencia de supervivencia a 1 año y PFS en el punto de referencia de 1 año
    • DoR
    • Cambios en el marcador tumoral Ca 19.9
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study
    A lo largo del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    ULTIMA VISITA ULTIMO PACIENTE EN EL ENSAYO
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 92
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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