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    Summary
    EudraCT Number:2010-024496-37
    Sponsor's Protocol Code Number:1716-12
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-14
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2010-024496-37
    A.3Full title of the trial
    A PHASE I/IIa STUDY OF THE SAFETY, TOLERABILITY AND BIOLOGICAL EFFECT OF SINGLE AND REPEAT ADMINISTRATION OF THE SELECTIVELY REPLICATION-COMPETENT HERPES SIMPLEX VIRUS HSV1716 INTO THE TUMOUR-BEARING PLEURAL CAVITY (INTRAPLEURAL) IN PATIENTS WITH INOPERABLE MALIGNANT PLEURAL MESOTHELIOMA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety study of oncolytic virus HSV1716 in patients with mesothelioma
    A.3.2Name or abbreviated title of the trial where available
    Intrapleural delivery of HSV1716 in patients with mesothelioma
    A.4.1Sponsor's protocol code number1716-12
    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 SponsorVirttu Biologics Limited
    B.1.3.4CountryUnited Kingdom
    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 supportVirttu Biologics Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHerpes simplex virus lacking infected cell protein 34.5
    D.3.2Product code HSV1716
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrapleural use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Malignant Pleural Mesothelioma
    E.1.1.1Medical condition in easily understood language
    Cancer of the lining of the lung
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10059518
    E.1.2Term Pleural mesothelioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research objective is to investigate whether HSV1716 is safe and well-tolerated when administered directly into the cavity that surrounds and protects the lungs (pleural cavity) of patients with a type of cancer that originates from the linings of the pleural cavity (malignant pleural mesothelioma).

    The study will assess this question in the context of three groups of patients. One group will receive a single dose of HSV1716, the second group will receive two doses and the third group will receive four doses.
    E.2.2Secondary objectives of the trial
    The secondary question is to look for evidence of HSV1716 activity in the patients through the assessment of patient samples. In particular, the study will assess samples of pleural fluid for evidence that HSV1716 has been active in the patients tumours.

    Tumour measurements will also be calculated from scans (before and after treatment) to assess whether there is any correlation between HSV1716 activity and the tumour size.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients with histologically proven malignant pleural mesothelioma
    2.Patients with disease which is not amenable to potentially curative resection
    3.Patients with pleural effusions and/or ‘trapped lung’ who
    (i)have an existing indwelling pleural catheter for draining of excess pleural fluid or
    (ii)require the insertion of an indwelling pleural catheter to drain excess pleural fluid
    4.Patients with a performance status ≤ 2 (ECOG)
    5.Age of at least 18 years (at screening)
    6.Ability to give written informed consent as evidenced by signature on the patient consent form, to communicate well with the investigator and to comply with the expectations of the study
    E.4Principal exclusion criteria
    1.Patients likely to require palliative radio- or chemotherapy within 30 days
    2.Any evidence of uncontrolled cardiac or respiratory disease that would be a contra-indication for virus administration
    3.Any other serious medical or psychiatric disorder that would be a contra-indication for virus administration
    4.Acute active infection of any kind or other severe systemic disease or medical or surgical condition that is deemed significant by the principal investigator
    5. Patients with immunosuppressive disorders or on systemic steroids > 5mg prednisolone/day
    6.Pregnancy: women of childbearing potential not taking adequate contraception, and women who are breast feeding
    7.Previous treatment with investigational viral therapy products
    8.Administration of any unlicensed or investigational product within 8 weeks of entry to the study
    9.No prior or concurrent malignancy within 5 years other than basal cell carcinoma of the skin or in situ neoplasia of the cervix uteri
    10.Inadequate haematological function as defined by:
    Haemoglobin (Hb) < 10g/dl
    Neutrophil Count < 1.5 x 10^9/l
    Platelets < 100 x 10^9/l
    11.Deranged liver function tests: serum bilirubin ≥ 1.5 x upper limit of normal reference range for laboratory; transaminases ≥ 5 x upper limit of normal reference range
    12.Patients with inadequate renal function: serum creatinine ≥ 1.5 x upper limit of reference range for laboratory
    13.Patients whose indwelling catheter is not of the type approved by the sponsor for use in the study
    14.Outwith any of the inclusion criteria above or considered unsuitable for entry into the study in any other way at the discretion of the principal investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to assess the safety and tolerability of single and repeat intrapleural administrations of HSV1716 in patients with inoperable MPM. This will be assessed by physical examination, full blood counts, biochemical profile, immunological status and adverse event reporting.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For patients receiving a single dose (treatment day 1), this end point will be evaluated at follow-up visits on days 3, 5, 8, 15, 22, 29 and 57.

    For patients receiving two doses (treatment days 1 and 8), this end point will be evaluated on treatment days and at follow-up visits on days 10, 12, 15, 22, 29 ,36 and 57.

    For patients receiving four doses (treatment days 1, 8, 15 and 22), this end point will be evaluated on treatment days and at follow-up visits on days 17, 19, 22, 29, 36, 43, 50 and 57 (first 3 patients recruited) and on days 24, 26, 29, 36, 43, 50 and 57 (second group of 3 patients).

    Further details are shown in tabular form in Section 5.1 of the Protocol v2.0.
    E.5.2Secondary end point(s)
    The secondary objective is to obtain evidence of HSV716 replication and
    lysis of MPM cells through analysis of pleural fluid and serum samples for
    evidence of cell death and/or HSV1716 replication and/or changes in
    appropriate biomarkers (for example mesothelin, osteopontin, VEGF,
    M30 and M65).

    A subsidiary endpoint will be tumour measurement as recorded by CT
    scans and assessed using the modified RECIST criteria for MPM.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Samples will be collected for evaluation of the secondary endpoint at each scheduled visit during both the treatment phase and for 28 days following the last treatment. The schedule of visits for the patient cohorts is as set out in E5-1.

    For all patients, CT scans will be conducted to obtain tumour measurement at screening, day 29 and 57.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Biological effect
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of trial is defined as the completion of last patient follow-up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    No such arrangements are in place to continue provision of HSV1716 outside the study. "Named patient use" may be considered on a case by case basis at the request of the investigator.
    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 Decision2011-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-14
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