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    Summary
    EudraCT Number:2016-001459-28
    Sponsor's Protocol Code Number:IMM-101-011
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-23
    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 number2016-001459-28
    A.3Full title of the trial
    A Novel Phase I/IIa Open label Study of IMM 101 in Combination with Selected Standard of Care (SOC) Regimens in Patients with Metastatic Cancer or Unresectable Cancer at Study Entry.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of IMM 101 in combination with various standard cancer treatments in patients with advanced cancer or cancer which cannot be removed by surgery.
    A.3.2Name or abbreviated title of the trial where available
    MODULATE
    A.4.1Sponsor's protocol code numberIMM-101-011
    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 Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address6-9 The Square
    B.5.3.2Town/ cityStockley Park, Uxbridge
    B.5.3.3Post codeUB11 1FW
    B.5.3.4CountryUnited Kingdom
    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 nameHeat-killed whole cell Mycobacterium 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.3.11 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 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 Cancer or Unresectable Cancer
    E.1.1.1Medical condition in easily understood language
    Cancer that has spread from the place where it first started, to another place in the body or cancer which cannot be removed by surgery
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10028980
    E.1.2Term Neoplasm
    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 primary objective of the study is to provide safety data for IMM 101 in combination with a number of selected chemotherapy regimens
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to provide:
    Safety and tolerability data for extended admininstration (beyond 28 weeks) of IMM 101 in combination with a number of selected chemotherapy regimens.
    Preliminary data regarding the activity of IMM 101 (in terms of response to treatment) in combination with recognised SOC in a number of different tumour types.
    Disease outcome data.
    Monitoring of selected markers of tumour burden and immunological status in patients taking IMM-101
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study if they:
    1. Have metastatic or unresectable cancer and are considered by their physician to be indicated for a new line of SOC chemotherapy, as listed
    2. Are ineligible for a disease specific clinical study with IMM 101
    3. Have an estimated life expectancy greater than 3 months (from Day 0)
    4. Give signed informed consent for participation in the study
    5. Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of ≤2 at Day 0.
    6. Have adequate bone marrow, hepatic and renal function including the following:
    a.Haemoglobin (Hb) ≥9.0g/dL, absolute neutrophil count ≥1.5 x 109/L, platelets ≥75 x 109/L
    b.Total bilirubin ≤1.5 x upper limit of normal (ULN), excluding cases where elevated bilirubin can be attributed to Gilbert's Syndrome
    c. Aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine transaminase (ALT; serum glutamate pyruvate transaminase [SGPT]) ≤5 x ULN
    d. Creatinine ≤1.5 x ULN
    e. Serum albumin >28g/L
    f. International normalised ratio (INR) <1.5 or a prothrombin time/partial thromboplastin time (Pt/PTT) within normal limits
    g. C reactive protein (CRP) <20 mg/L for patients with solid tumours
    7. Are aged ≥18 years.
    E.4Principal exclusion criteria
    Patients will be ineligible if one or more of the following statements are applicable:
    1. Patient has previously received treatment with IMM 101
    2. Patient is currently part way through a course of chemotherapy
    3. Patient is receiving concomitant treatment with another investigational product
    4. Patient has received an investigational drug within the 4 weeks prior to IMM-101 administration
    5. Patient has significant cardiovascular disease as defined by:
    a. History of congestive heart failure requiring therapy
    b. History of unstable angina pectoris or myocardial infarction up to 6 months prior to study entry
    c. Presence of valvular heart disease
    d. Presence of a ventricular or supra ventricular arrhythmia requiring ongoing treatment
    e. Left ventricular ejection fraction (LVEF) <50% (or less than the institutional norm)
    6. Patient has any previous or concurrent malignancy. Patients will not be excluded if they have 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 prior to Screening and there are no signs of recurrence
    7. Patient has co existing active infection or medical condition which, in the Investigator’s judgement, will substantially increase the risk associated with the patient’s participation in the study
    8. Patient has uncontrolled hypercalcaemia (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] v4.0[1] >Grade 1)
    9. Patient is pregnant or a breast feeding woman. Female patients with reproductive potential must have a negative serum pregnancy test (β human chorionic gonadotropin [β hCG]) within 72 hours prior to start of the study. Both women and men must agree to use a medically acceptable, effective method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable, effective methods of contraception include intrauterine device (IUD), intrauterine hormone releasing system (IUS), oral contraceptive (progestogen only oral contraception that does not inhibit ovulation is not an acceptable method), bilateral tubal occlusion, vasectomised partner, and subdermal implant
    10. Patient has used depot corticosteroids in the 6 weeks before initiation of Screening (signing of the informed consent form [ICF])
    11. Patient has had chronic use of 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 IMM-101
    12. Patient has received a blood transfusion within 4 weeks prior to Screening
    13. In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability as measured by
    • AEs
    • Laboratory abnormalities
    • Local injection site reactions
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to and including 30 days after the end of the patients participation in the study
    E.5.2Secondary end point(s)
    Activity as defined by
    • Response to treatment, (defined as immune related Stable Disease [irSD], immune related Partial Response [irPR] and immune related Complete Response [irCR]) as assessed by the Investigator
    • Overall survival (OS)
    • Immunological markers (Serum: micro ribonucleic acid [miRNA] panel, circulating metabolites. FACS: immune cell quantifications: TruCulture: cytokines, chemokines, immune mediators, functional immune cell assays, tumour markers)
    •Additional evaluations may be considered as driven by the evolving understanding of the mechanism of action, technical feasibility, and any other clinical or immunological information that may become available.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Response to treatment will be measured at Week 28.
    Overall survival will be measured at the end of study
    Other secondary endpoints will be measured periodically throughout the study
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 300
    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)
    The study will continue until all patients have either withdrawn from the study or died. Give that all patients will have advanced or unresectable cancer at study entry, it is unlikely that many patients will complete the 4 year 6 month maintenance phase. However, in the event that a patient has a good response to treatment and completes the study, the patient will be offered the opportunity to continue to receive IMM-101 in the context of a compassionate use protocol or patient registry.
    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 Decision2016-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-08-30
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