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    Summary
    EudraCT Number:2013-002755-15
    Sponsor's Protocol Code Number:GM-IMAB-002-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-27
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-002755-15
    A.3Full title of the trial
    A first-in-human dose escalation and dose finding phase I/II trial of IMAB027 in patients with recurrent advanced ovarian cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    recurrent advanced ovarian cancer
    A.4.1Sponsor's protocol code numberGM-IMAB-002-01
    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 SponsorGanymed Pharmaceuticals AG
    B.1.3.4CountryGermany
    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 supportGanymed Pharmaceuticals AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGanymed Pharmaceuticals AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressAn der Goldgrube 12
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.6E-mailClinOps@ganymed.ag
    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/794326/2012
    D.3 Description of the IMP
    D.3.1Product nameIMAB027
    D.3.2Product code IMAB027
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNIMAB207
    D.3.9.2Current sponsor codeIMAB027
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number216
    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 Yes
    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
    recurrent advanced ovarian cancer
    E.1.1.1Medical condition in easily understood language
    advanced cancer of the ovary
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10033130
    E.1.2Term Ovarian cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10016183
    E.1.2Term Fallopian tube cancer NOS
    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
    Phase I:
    Assess safety and tolerability
    Phase II:
    Assess antitumoral activity
    E.2.2Secondary objectives of the trial
    Phase I:
    Assess pharmacokinetics
    Assess antitumoral activity
    Assess immunogenicity
    Characterization of biomarkers

    Phase II:
    Assess safety and tolerability
    Determine pharmacokinetics
    Determine immunogenicity
    Characterization of biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Signed written informed consent
    (2) Female patients ≥18 years of age, no upper age limit.
    (3) Histologically or cytologically confirmed CLDN6+ ovarian cancer of any histology type including primary peritoneal or fallopian tube tumors (histological documentation of the original primary tumor is required via a pathology report) that are either:
    Patients with symptomatic recurrence
    • Primary-refractory to platinum therapy (as evaluated after at least 2 cycles of platinum-containing therapy); OR
    • Platinum-resistant population: relapsed <6 months after platinum-therapy; OR
    • Patients with recurrence after ≥2 lines of standard therapy of which at least one is platinum-based OR
    Patients with asymptomatic recurrence
    • Patients with asymptomatic disease in progression detected by increase of CA125 levels according to GCIG criteria during systematic follow-up (“CA125-rise” patients), who had at least one line of standard treatment
    (4) Performance status ECOG 0-2
    (5) Patients with measurable, non-measurable, or evaluable disease:
    • Evaluable disease: defined as a confirmed CA-125 ≥2 x ULN
    • Measurable disease (RECIST 1.1): defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
    • Non-measurable disease: includes patients with symptomatic ascites or pleural effusions, lesions that do not meet RECIST 1.1 criteria or biopsy proven recurrence. Patients with clinically evident non-measurable disease must have either an elevated CA125 or histological confirmation of recurrence
    (6) Availability of a FFPE tumor tissue sample or tumor cell positive paracentesis fluid samples (abdominal- or pleural cavity) for the assessment of CLDN6 positivity
    (7) Life expectancy of >12 weeks
    (8) Adequate organ function defined as:
    • Adequate hematologic function (ANC ≥1000/µl, platelets ≥100.000/µl, hemoglobin ≥8.5 g/dl [5.6 mmol/l] (can be post transfusion))
    • Adequate renal function (serum creatinine ≤1.5 mg/dl [114.5 µmol/l] or creatinine clearance rate ≥30 ml/min)
    • Adequate liver function (serum total bilirubin ≤2 x ULN, AST/ALT ≤3 x ULN)
    (9) Patients of child-bearing potential must have a negative β-HCG urine test within 72 hours before receiving treatment
    E.4Principal exclusion criteria
    (1) Patient is pregnant or breast-feeding
    (2) Prior allergic reaction or intolerance to a monoclonal antibody (humanized or chimeric)
    (3) Any prior anti-tumor therapy within 14 days prior to the start of IMAB027 treatment
    (4) Other concurrent anticancer therapies
    (5) HIV infection in medical history or active, medicinally not well controlled Hepatitis B or C infection
    (6) History of any one or more of the following cardiovascular conditions within the past 6 months:
    • Myocardial infarction (T-Wave/Non-T-Wave)
    • Unstable angina pectoris
    • Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
    • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT). Patients with recent DVT who have been or are treated with therapeutic anti-coagulant agents (excluding warfarin) for at least 6 weeks are eligible
    (7) Other investigational agents or devices concurrently or within 14 days before start of IMAB027 treatment. If half-life of prior investigational agent is >7 days, distance to prior investigational agent should be at least two half-lives. Patients with prior radiotherapy are allowed, if discontinued at least 14 days prior to the first dose of study medication. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
    (8) Any hemoptysis or bleeding event that is clinically relevant within 2 weeks of first dose of study drug
    (9) Clinical symptoms of brain metastases or tumor-associated spinal cord compression.
    (10) Need for continuous, systemic immunosuppressive therapy. Concurrent systemic immunosuppressive therapy, in particular systemic corticoids must be stopped 2 weeks prior first treatment. Inhaled and topically applied steroids are allowed. Systemic steroids should be avoided as long as patient is under study medication.
    (11) Any other medical condition that would, in the opinion of the Investigator, limit the patient’s ability to complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: Safety profile including type, frequency, severity, relationship of adverse events to study treatment, dose limiting toxicities, maximum tolerated dose
    Phase II: Same as for Phase I and additionally disease control rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: Safety will be assessed throughout the whole study. DLT/MTD will be assessed prior to inclusion of a new patient (stage I) and prior to next dose level or prior to each new dose level (stage II)
    Phase II: CTs or MRIs and tumor marker analysis will be performed every 6 weeks.
    E.5.2Secondary end point(s)
    Phase I:
    (1) Cmax, AUC, terminal half-life and related pharmacokinetic parameters
    (2) Frequency of anti-IMAB027 antibodies
    (3) Disease control rates (CR, PR, SD)
    (4) Ratio previous/current remission time intervals
    (5) Overall survival
    Phase II:
    (1) Safety profile including type, frequency, severity, relationship of adverse events to study treatment, dose limiting toxicities, maximum tolerated dose
    (2) Objective response rate
    (3) Ratio previous/current remission
    (4) Progression free survival
    (5) Overall survival
    (6) Duration of response
    (7) Cmax, AUC, terminal half-life and related pharmacokinetic parameters
    (8) Frequency of anti-IMAB027 antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I: PK, Biomarkers and ADAs will be analyzed at specific timepoints throughout the study. CTs/MRIs and tumor marker analysis will be performed every 6 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity assessment
    Blood tumor marker assessment
    Biomarker characterization
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Belgium
    Bulgaria
    Germany
    Russian Federation
    Ukraine
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    E.8.9.1In the Member State concerned months1
    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 months1
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 99
    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)
    After the end of the participation in the trial, the patients will receive treatment at their investigator’s discretion according to current local medical practice without the sponsor’s involvement.
    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 Decision2013-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-04
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