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    Summary
    EudraCT Number:2011-003958-85
    Sponsor's Protocol Code Number:IMM-101-007
    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:2011-12-05
    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 number2011-003958-85
    A.3Full title of the trial
    A Phase II, Single Arm, Investigative Study of IMM-101 in Combination with Radiation Induced Tumour Necrosis in Patients with Previously Treated Colorectal Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMM101 treatment, combined with CyberKnife, in Colorectal Cancer
    A.4.1Sponsor's protocol code numberIMM-101-007
    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 SponsorImmodulon Therapeutics Ltd
    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 supportImmodulon Therapeutics Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmodulon Therapeutics Ltd
    B.5.2Functional name of contact pointClinical Trials Administrator
    B.5.3 Address:
    B.5.3.1Street Address22 Devonshire Place B2
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1G 6JA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044020321935680044
    B.5.5Fax number004402072242805
    B.5.6E-mailinfo@immodulon.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMycobacterium obuense
    D.3.2Product code IMM-101
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMycobacterium obuense
    D.3.9.2Current sponsor codeIMM-101
    D.3.9.3Other descriptive nameheat killed whole cell Mycobacterium obuense
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeWhole cell heat killed mycobacterium
    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 colorectal cancer
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of IMM-101 in combination with radiation induced tumour necrosis (induced by CyberKnife treatment) in patients with colorectal cancer with metastatic disease who have received prior chemotherapy.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of IMM-101 in combination with radiation induced tumour necrosis (induced by CyberKnife treatment) in patients with colorectal cancer with metastatic disease who have received prior chemotherapy

    To conduct an eploratory investigation of selected markers of tumour burden and immunological status in patients with colorectal cancer with metastatic disease treated with IMM-101 and radiation induced tumour necrosis (induced by CyberKnife treatment).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are male or female; aged ≥18 years.
    2. Have a histologically confirmed colorectal adenocarcinoma.
    3. Have documented evidence of disease progression following at least one line of chemotherapy.
    4. Have no further standard chemotherapy options available or the patient has refused further chemotherapy.
    5. Have metastatic lesions in at least two sites in the liver (+/- other sites) suitable for bidimensional and volumetric evaluation by CT scan.
    6. Have WHO performance status of 0-2.
    7. Have a Cockcroft calculated Glomerular Filtration Rate of > 40mL/min at screening.
    8. Have a life expectancy, in the opinion of the Investigator, of >3 months from screening.
    9. Provide written informed consent to participate as shown by a signature and date on the patient's informed consent form (ICF).
    E.4Principal exclusion criteria
    1. Patient has evidence of central nervous system metastasis.
    2. Patient has severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments.
    3. Patient has any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years earlier and there are no signs of recurrence.
    4. Patient has serum albumin < 30 g/L at screening.
    5. Patient has a C-reactive protein (CRP) > 70 mg/L at screening.
    6. Patient has transaminases (ALT or AST) > 5 X Upper Limit of Normal at screening.
    7.Patient has a bilirubin level > 2 X Upper Limit of Normal at screening.
    8. Patient has had radiotherapy in the 12 weeks before screening.
    9. Patient has used depot corticosteroids in the 6 weeks before screening.
    10. Patient has had chronic use of any systemic corticosteroids (>10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2-week period before the first administration of study drug.
    11. Patient of child-bearing potential who is not using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]). Those patients that utilise hormonal contraceptives must have used the same method for at least three months before study dosing.
    Patients of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile.
    12. Patient who is pregnant, breast feeding or planning a pregnancy during the course of the study. Where appropriate, a pre-treatment serum pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.
    13. Patient has been administered any investigational product in the 3 months before screening.
    14. Contraindication to CT scan, e.g., allergy to iodine based contrast medium.
    15. Patient has a surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
    16. Patient has presence of any uncontrolled concomitant disease (e.g., unstable angina pectoris, congestive heart failure, myocardial infarction, cardiac arrhythmias, uncontrolled severe hypertension) which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
    17. Patient has a history of serious adverse reaction or serious hypersensitivity to any drug that in the opinion of the Investigator may raise a safety concern.
    18. Patient has had any previous treatment with IMM-101 or related mycobacterial immunotherapy (prior BCG vaccination against TB is allowed).
    19. Patient is known to have a history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C.
    20. Patient is unable or unwilling to comply with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The disease stabilisation rate at 24 weeks defined as the proportion of patients with a complete response, partial response or stable disease in accordance with immune-related response criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    Objective response rate at 12, 24, 36 and 48 weeks
    Disease stabilisation rate at 12, 36 and 48 weeks
    Overall disease stabilisation rate
    Overall response rate
    Progression-free survival at 12, 24, 36 and 48 weeks
    Survival at 12, 24, 36 and 48 weeks
    Tumour Markers at 12, 24, 36 and 48 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 24, 36 and 48 weeks
    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 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.8.4.1Number of sites anticipated in Member State concerned6
    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 study is defined as last visit of last patient
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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.1.1.1In 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state29
    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)
    At the end of the study,any surviving patients will be offered the opportunity to enter a long term follow-up extension study (a separate protocol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-27
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