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    Summary
    EudraCT Number:2017-003585-27
    Sponsor's Protocol Code Number:GNS561CLIQ0211
    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:2017-10-06
    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 number2017-003585-27
    A.3Full title of the trial
    Phase 1/2a study to evaluate the safety, activity, and pharmacokinetics of escalating doses of GNS561 in patients with primary or secondary liver cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2a study to evaluate the safety, activity, and pharmacokinetics of escalating doses of GNS561 in patients with primary or secondary liver cancer
    A.4.1Sponsor's protocol code numberGNS561CLIQ0211
    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 SponsorGENOSCIENCE PHARMA
    B.1.3.4CountryFrance
    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 supportGENOSCIENCE PHARMA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGENOSCIENCE PHARMA
    B.5.2Functional name of contact point Clinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address10 rue d'Iéna
    B.5.3.2Town/ cityMarseille
    B.5.3.3Post code13006
    B.5.3.4CountryFrance
    B.5.4Telephone number33491 26 99 50
    B.5.5Fax number33491 26 99 51
    B.5.6E-mailcontact@genosciencepharma.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.3.2Product code GNS561
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number 1914148-72-3
    D.3.9.2Current sponsor codeGNS561
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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.IMP: 2
    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.3.2Product code GNS561
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number 1914148-72-3
    D.3.9.2Current sponsor codeGNS561
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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
    Hepatocellular carcinoma
    Intrahepatic cholangiocarcinoma
    Pancreatic adenocarcinoma with liver metastasis
    Colorectal cancer with liver metastasis
    E.1.1.1Medical condition in easily understood language
    Primary or Secondary Liver Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077738
    E.1.2Term Hepatocellular carcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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 1:
    • To characterize the safety and tolerability of GNS561
    • To identify the recommended Phase 2 dose (RD)
    • To characterize the PK of GNS561

    Phase 2a:
    • To characterize the safety and tolerability of GNS561
    • To identify evidence of antitumor activity (tumor control rate : overall response rate + SD by RECIST 1.1)
    E.2.2Secondary objectives of the trial
    Exploratory objectives:
    • Pharmacodynamics (PD) biomarker expression in blood including α-fetoprotein (AFP), CA-19-9 and CEA.
    • PD biomarker expressions in liver biopsies ZIP4, Ki67 expression by immunostaining and an autophagy marker (LC3-II).
    • To assess the liver/plasma ratio of GNS561 after repeated dosing
    • To assess the anti-fibrotic effect of GNS561 in liver after repeated dosing (for Phase 2a only) by a FibroScan® and calculation of a fibrosis score (FibroTest®/FibroSURE™)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females ≥ 18 years of age.
    2. Histologically confirmed and documented locally advanced or metastatic hepatocarcinoma (HCC) that is deemed not appropriate for curative therapy or histologically confirmed and documented locally advanced or metastatic intrahepatic carcinoma (iCCA) or or histologically confirmed and documented pancreatic ductal adenocarcinoma (PDAC) with liver metastasis or histologically confirmed and documented colorectal cancer (CRC) with liver metastasis.
    3. Liver tumor burden < 50% of the liver (per Investigator judgment).
    4. Antiviral therapy required in Hepatitis B virus patients (Hepatitis B antigen positive)
    5. Child-Pugh score A (≤ 6, Appendix C), with no evidence of prior cirrhotic decompensation within last 12 months prior to enrollment.
    6. a. Previously exposed, intolerant or refractory to at least another registered therapy and for which no curative therapy is available for HCC.
    b. Previously exposed, intolerant or refractory to at least one first line chemotherapy for ICC.
    c. Previously exposed, intolerant or refractory to at least one first line chemotherapy and for which no curative therapy is available for PDAC patients.
    d. Previously exposed, intolerant or refractory to at least one first line chemotherapy with fluoropyrimidine and/or oxaliplatin and/or irinotecan and for which no curative therapy is available for CRC patients.
    7. Neither sorafenib nor other anticancer therapy such as chemotherapy in the 4 weeks or 5 half-lives, whichever is greater, prior to the first dose of GNS561. This treatment-free period must be extended to 6 weeks in the case of nitrosoureas and 8 weeks for previous treatment with monoclonal antibodies. The following treatment is allowed: palliative radiation to bone metastases within 2 weeks prior to first dose.
    8. Willing to have liver biopsy at the beginning of Cycle 2 (Day 1 ) in escalation phase.
    9. Presence of a measurable tumor per RECIST v1.1 criteria (Appendix E)
    10. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Appendix D)
    11. Life expectancy ≥ 12 weeks
    12. Adequate hematologic function prior to the first dose of GNS561, defined as:
    a. Absolute neutrophils count ≥ 1500 cells/µL
    b. Hemoglobin ≥ 10 g/dL with no transfusion within 4 weeks prior to first planned dose of GNS561
    c. Platelet count > 50,000/µL with no transfusion within 2 weeks prior to first planned dose of GNS561
    13. Adequate renal function prior to first dose, defined as
    a. Serum creatinine < 1.5 upper limit of normal (ULN)
    b. Creatinine clearance ≥ 50 mL/min/m2 (by Cockroft-Gault equation of 24-hour urine) if creatinine ≥ 1.5 X ULN
    14. Adequate hepatic function prior to first dose, defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 x ULN
    15. Women patients of childbearing potential must have a negative serum/urine pregnancy test at screening and baseline, and be willing to use a medically acceptable form, as judged by the Investigator and Sponsor, of contraception (e.g., hormonal birth control, intrauterine device [IUD], or bilateral tubal occlusion or abstinence or whose partner had a vasectomy at least 2 years before screening). The patient should be advised to continue the contraception for at least 6 months following the completion of dosing. Women with cessation for > 24 months of previously occurring menses, or women of any age who have had a hysterectomy, or have had both ovaries removed will be considered to be of non-childbearing potential.
    16. Male patients of reproductive potential must be willing to use one acceptable method of contraception, as judged by the Investigator and Sponsor, as described in Inclusion Criteria 15 and/or to refrain from donating sperm from the time of screening through at least six months following the completion of dose administration.
    17. Amenable to computed tomography (CT) with 3 or 4 phase liver or magnetic resonance imaging (MRI) of abdomen and pelvis, and CT of chest, or MRI of whole body, for initial tumor size measurements and subsequent follow-up.
    18. Absence of other clinically relevant abnormalities for screening laboratory test results as judged by the Investigator and Sponsor.
    19. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    20. Be willing to abstain from alcohol from signing of informed consent through Week 5 (completion of PK sampling at the beginning of Cycle 2).
    21. Able to understand and provide written informed consent.
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding mothers
    2. Prior history of acrodermatitis enteropathica or known ZIP4 genetic mutations
    3. Any known history of encephalopathy
    4. Known esophageal varices with recent history of bleeding (within previous 2 months)
    5. Clinically significant ascites or paracentesis
    6. Concurrent hematologic malignancies or other malignancy, with the exception of:
    a) Curatively resected non-melanoma skin cancer;
    b) Curatively treated cervical carcinoma in situ.
    7. Known untreated or symptomatic brain metastases
    8. Prior antitumor treatment, including chemotherapy, biologic, experimental, hormonal or radiotherapy within 4 weeks of first dose of GNS561with the following exceptions:
    a. Maintenance hormonal therapy for metastatic prostate and breast cancer
    b. Hormone-replacement therapy or oral contraceptives
    c. Palliative radiation to bone metastases within 2 weeks prior to first dose
    9. Previous treatment with ZIP4 targeted therapy
    10. Known allergic reaction to quinoline derivatives (e.g., quinine, chloroquine, Mefloquine)
    11. Presence of residual toxicities of ≥ Grade 2 after prior antitumor therapy ≤4 weeks prior to first dose. Grade 1 toxicities related to previous treatments are acceptable at the time of the first planned dose of GNS561, as well as any alopecia.
    12. Chronic treatment with immunosuppressive agents(like steroids) ≤ 6 weeks prior to first planned dose of GNS561.
    13. Major surgical procedures, open biopsy or significant traumatic injury ≤ 4 weeks prior to first dose of GNS561 or anticipation of major surgical procedure during the course of the trial, minor surgical procedures ≤ 1 week of first planned dose
    14. Any clinically significant cardiovascular condition as judged by the Investigator
    15. Severe or uncontrolled renal condition
    16. Untreated chronic hepatitis B
    17. Known history of immunodeficiency diseases (e.g., active HIV)
    18. Use of any prohibited concomitant medications within 14 days of the Baseline/Day 1 visit
    19. Known current alcohol (> 20g/ Day in women and >30g/ Day in men) or substance abuse
    20. Malabsorption issues (e.g., gastric bypass or gastrectomy patients)
    21. Patient with a mental or legal disability
    22. Participation in any investigational clinical investigation ≤4 weeks prior to first planned dose of GNS561 or longer if required by local regulations, and for any other limitation of participation based on local regulations
    23. Known clinically significant or life threatening organ or systemic disease such that in the opinion of the Investigator, the significance of the disease will compromise the patient’s participation in the trial
    24. Is a participant or plans to participate in another investigational clinical study, while taking part in this study.
    25. Known intolerance or hypersensitivity to the active ingredient or to one of the components of the study drug
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • Incidence and nature of DLTs by dose level during the 4 week dose escalation phase
    • Incidence, nature, and severity of adverse events
    • Change in vital signs, clinical laboratory (chemistry and hematology) values, urinalysis, electrocardiogram (ECGs)

    Efficacy:
    • Response rate (CR+ PR)
    • Disease control rate (CR+PR+SD)
    • Progression free survival

    Pharmacokinetics:
    • GNS561 PK over first 48 hours following first and repeated dose in Cycle 1 and Cycle 2
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety evaluation: at each visit

    Efficacy evaluation: on week 9 and all 8 weeks (tumor RECIST)

    PK evaluation: D1, D2, D3 of Cycle 1 and Cycle 2. Weekly during Cycle 1 and D1 of Cycle 3, Cycle 4 and Cycle 5.
    E.5.2Secondary end point(s)
    Exploratory endpoints:
    • PD biomarker expressions in blood including AFP for HCC patients, CEA and CA-19-9 for iCCA, PDAC and CRC patients.
    • PD biomarker expressions in liver biopsies including ZIP4 and Ki67 expression by immunostaining and an autophagy marker (LC3-II).
    • Liver/plasma ratio of GNS561 after repeated dosing at the beginning of Cycle 2
    • Assessment of the anti-fibrotic effect of GNS561 in liver after repeated dosing (for Phase 2a only) by a FibroScan® and calculation of a fibrosis score (FibroTest®/FibroSURE™) for patients with primary liver cancer.
    E.5.2.1Timepoint(s) of evaluation of this end point
    AFP, CA-19-9 and CEA : at screening, then beginning of each cycle from C2 and final follow-up visit.
    FibroScan and fibrosis score: at baseline and every 6 months.
    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 Yes
    E.6.6Pharmacokinetic Yes
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Dose escalating (phase 1), followed by a continuation phase (phase 2)
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 100
    F.4.2.2In the whole clinical trial 122
    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)
    None
    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 Decision2017-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
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