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    Summary
    EudraCT Number:2011-004501-24
    Sponsor's Protocol Code Number:CT-2011-01
    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:2011-12-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-004501-24
    A.3Full title of the trial
    Phase II study to evaluate the safety, tolerability and efficacy of CT-011 administered intravenously to patients with metastatic
    melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety, tolerability and efficacy of CT-011 administered intravenously to patients with metastatic
    melanoma
    A.3.2Name or abbreviated title of the trial where available
    Not available
    A.4.1Sponsor's protocol code numberCT-2011-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01435369
    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 SponsorCureTech Ltd.
    B.1.3.4CountryIsrael
    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 supportCureTech Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCureTech Ltd.
    B.5.2Functional name of contact pointVice President, Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address42 Hayarkon Street
    B.5.3.2Town/ cityYavne
    B.5.3.3Post code81227
    B.5.3.4CountryIsrael
    B.5.4Telephone number+97289324000
    B.5.5Fax number+9728324001
    B.5.6E-mailhagit@curetechbio.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 nameCT-011
    D.3.2Product code CT-011
    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.3.9.1CAS number 1036730-42-3
    D.3.9.2Current sponsor codeCT-011
    D.3.9.3Other descriptive namehBAT, HUBAT, CTActibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number18 mg/ml to 22mg/ml
    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) Yes
    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
    Metastatic melanoma
    E.1.1.1Medical condition in easily understood language
    Metastatic melanoma
    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 LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    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
    The objective of this Phase II study is to evaluate the safety, tolerability and efficacy of CT-011 administered intravenously to patients with metastatic melanoma
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically or cytologically documented diagnosis of advanced/inoperable metastatic melanoma of skin, mucosal, or unknown origin are eligible, provided they fulfill the following conditions:
    2. Patient age is 18 years or older with measurable (at least 1 cm) metastatic disease;
    3. Stage IV (M1a,b,c) that is clearly progressive since last therapy.
    4. They have ECOG performance status of 0 or 1.
    5. Patients with a maximum of 3 prior lines of treatment for metastatic disease including those who have received prior approved or investigational treatments,
    those who are not deemed appropriate for or who have refused treatment with such agents, or those for whom such treatments are deemed not in their immediate best interest can be enrolled.
    6. Expected survival of at least 4 months
    7. Must be at least 21 days since surgery and/or radiation therapy and at least 4 weeks since last treatment with either approved standard therapy or investigational therapies including cytotoxic chemotherapy, interferon alpha or molecularly targeted therapies, and at least 6 weeks from HD IL-2 or ipilimumab
    therapy and have adequately recovered (to at least Grade 1 level) from adverse effects of these therapies and have evidence of documented disease progression.
    8. Values of laboratory tests required for registration: WBC: 2000/uL or greater,
    lymphocytes 1.0X 109/L or greater, ANC: 1000/uL or greater, hemoglobin: 9 g/dL
    or greater, creatinine: </=1.5 mg/dL, AST and ALT: </= 2.5 x ULN for subjects
    without liver metastasis or, </= 5 X ULN for liver metastases, bilirubin: </= 2
    mg/dL, LDH </= 2 X ULN.
    9. No significant intercurrent illness such as a serious infection which requires
    intravenous antibiotics. No active or chronic infection with HIV, Hepatitis B or
    Hepatitis C.
    10. Patients that received interferon, GM-CSF, or experimental cancer vaccines for melanoma in the adjuvant setting are eligible. Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and any toxicity has returned to Grade 1
    or baseline (patients with mild lymphedema following radiotherapy are allowed).

    11. Patients with brain metastases should be at least 4 weeks from craniotomy and resection or stereotactic radiosurgery. MRI/CT of the brain performed within 2 weeks from screening fails to show new metastases and they are off of steroids for at least 2 weeks. Patients previously treated with whole brain radiotherapy are eligible if they are without tumor progression in the brain at least 8 weeks from completion of radiotherapy and are asymptomatic and off of steroids for at least 2 weeks.
    12. Fertile patients and/or their partners must declare simultaneous use of two forms of birth control during the treatment period and up to 4 months after the last treatment of CT-011. The decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
    13. Ability and willingness to give informed consent.
    E.4Principal exclusion criteria
    1. Patients with uveal melanoma.
    2. Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
    3. Known major immunodeficiency
    4. Unresolved immune related adverse events following prior biological therapy
    5. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent and anti-CTLA4 therapy given within 6 weeks prior to first dosing.
    6. Prior anti PD-1, anti PD-L1 or PD-L2 therapy.
    7. More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments. Questionable situations should be discussed with the Study Medical Monitor.
    8. Metastases associated with active bleeding expected to require transfusion in the next 3 months
    9. Patients with New York Heart Association class II, III or IV disease or arrhythmia requiring treatment. Borderline cases must be discussed with the Study Medical Monitor.
    10. Patients with clinically significant impairment of pulmonary function due to chronic bronchitis or chronic obstructive pulmonary disease (COPD). History of major lung resection or major underlying chronic bronchitis, COPD or restrictive
    lung disease should be evaluated with pulmonary function tests: Patients with the FEV1 <1.5 liters or <50% or FVC <50% of predicted should be excluded.
    Borderline cases must be discussed with the Study Medical Monitor.
    11. Patients on corticosteroids (inhaled or oral steroids for treating mild asthma treated by a low dose at a maximum of 500 micrograms per day for up to 10 consecutive days or allergies or topical steroids for localized -< 5% of body surface area- dermatitis are allowed) or any other type of immunosuppressive
    agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide)
    12. Patients with history of second malignancies are eligible provided that they have been free of recurrence from second malignancy for at least 5 years, except that the following are allowed: basal cell cancer (BCCa) or squamous cell cancer (SCCa) of the skin, or carcinoma in situ of the breast or cervix or localized
    prostate cancer detected via biopsy only and being treated with “watchful waiting”. Each case must be discussed with the Study Medical Monitor prior to registration.
    13. Patients with symptomatic uncontrolled brain metastasis that is associated with significant brain edema requiring steroid therapy. Patients with spinal cord metastasis or meningeal carcinomatosis.
    14. Patients who are ineligible for imaging by CT and MRI due to suspected or known allergy to contrasting agents or patients who are ineligible for CT scan and have an implanted pacemaker (thus ineligible for MRI).
    15. Women of child bearing potential who are pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 72 hours of first dosing or nursing.
    16. Any condition that, in the clinical judgment of the treating physician, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the objective response rate (ORR) by Immune
    Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-
    011
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be the objective response rate (ORR) after first administration of CT-011 that will record the best overall response from start of treatment until disease progression. Clinical responses will be evaluated by CT scan. Objective clinical responses will be determined by irRC. Response according to RECIST 1.1 will also be assessed and recorded. Complete response (irCR) or partial response (irPR) will be confirmed via subsequent assessment performed between 4 and 6 weeks later. ORR will be evaluated every 8-10 weeks for up to 12 months after first administration of CT-011.
    E.5.2Secondary end point(s)
    The secondary endpoints are to:
    o Safety and tolerability of CT-011
    o Progression-free survival from time of randomization, by irRC
    o Overall survival from time of randomization
    o Duration of response by irRC
    o Immunogenicity of CT-011
    o Monitoring peripheral lymphocyte cell surface markers: CD4, CD8,
    CD45RO, CD62L, CCR7, CD27, CD127, CD25, FoxP3 & CD279 (PD-1)
    (in US centers only)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will include the safety and tolerability of CT-011, the rate of progression- free and overall survival to be evaluated every 8-10 weeks for up to 12 months after first administration of CT-011, the duration of response,
    peripheral lymphocyte cell surface markers and the immunogenicity of CT-011. Blood samples for immunogenicity evaluation will be collected on Day 1, Week 16, 24, 34 and End of Study Visit.
    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 No
    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) 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 Yes
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Germany
    Israel
    Poland
    United Kingdom
    United States
    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
    A final study visit (End of Study Visit) will be performed for all patients after their last
    treatment. The End of Study Visit will be performed 15 days and no
    longer than 21 days after the patient has either:
    • Completed all the 27 visits specified under this Study Protocol (skipping of visits
    is allowed as specified under Sections 5.4 and 6.3); or,
    • Withdrawn from the study due to any of the reasons specified under Section 6.3.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1.1In 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 100
    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)
    When a patient is removed from the study, he/she will receive treatment according to the
    standard of care (SOC) in the medical center and will be followed-up according to the
    study schedule whenever possible.
    The Sponsor of the study will allow patients who have presented with at least partial
    remission to subscribe to a compassionate off-study treatment and continue so their
    treatment could continue at the same last dose and regimen of CT-011 they have been
    allocated to.
    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 Decision2012-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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