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    Summary
    EudraCT Number:2019-003847-31
    Sponsor's Protocol Code Number:ICT01-101
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-003847-31
    A.3Full title of the trial
    A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-human study of ICT01 in patients with advanced-stage, relapsed/refractory cancer
    A.4.1Sponsor's protocol code numberICT01-101
    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 SponsorImCheck Therapeutics, Inc.
    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 supportImCheck Therapeutics, Inc.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImCheck Therapeutics, Inc.
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address31 Chemin Joseph Aiguier
    B.5.3.2Town/ cityMarseilles
    B.5.3.3Post code13009
    B.5.3.4CountryFrance
    B.5.4Telephone number33698 46 56 44
    B.5.6E-mailpaul.frohna@imcheck.fr
    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 nameICT01
    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.3.8INN - Proposed INNICT01
    D.3.9.2Current sponsor codeict01
    D.3.9.3Other descriptive nameICT01
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Relapsed/refractory solid tumors or hematological cancers
    E.1.1.1Medical condition in easily understood language
    Relapsed/refractory solid tumors or hematological cancers
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066481
    E.1.2Term Hematological malignancy
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    Characterize the overall safety and tolerability profile of a range of intravenous (IV) doses of ICT01 as monotherapy, and in combination with pembrolizumab in patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers.
    Part 2
    Characterize the preliminary anti-tumor activity of IV ICT01 as monotherapy and in combination with pembrolizumab in patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers.
    E.2.2Secondary objectives of the trial
    Part 1
    1. Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of IV ICT01 administered to patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers
    2. Determine the recommended dose(s) for the expansion cohorts (Part2) for ICT01 as monotherapy and in combination with pembrolizumab
    3. Characterize the preliminary anti-tumor activity of a range of IV doses of ICT01 as monotherapy and in combination with pembrolizumab when administered to patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers

    Part 2
    1. Characterize the overall safety and tolerability of IV ICT01 as monotherapy, and in combination with pembrolizumab in patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers.
    2. Characterize the PK and PD of IV ICT01 administered to patients with advanced-stage, relapsed/refractory solid tumors or hematologic cancers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following criteria must be checked over the screening period and at baseline. ALL inclusion criteria must be met to include the subject in the study:
    Part1:
    1) Male or female aged ≥18 years
    2) Voluntarily signed written informed consent before performance of any study-related screening procedures
    3) Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer including:
    a. Group A: bladder, breast, colorectal, gastric, melanoma, ovarian, prostate and PDAC
    b. Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma
    c. Group C: melanoma, bladder, head and neck SCC, and non small cell lung cancer (approved indications in the US & EU for pembrolizumab)
    4) Willingness to undergo baseline and on-study tumor biopsies
    5) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    6) Life expectancy > 3 months as assessed by the Investigator
    7)Clinical labs:
    a. Hematology:
    - Hemoglobin ≥8.5 g/dL (equal to 5.28 mmol/L; transfusion dependent or independent);
    - Group A/C only:
    • platelet count ≥75 × 109/L;
    • lymphocyte count ≥0.5 × 109/L;
    • absolute neutrophil count ≥1.0 × 109/L;
    b. Liver enzymes:
    - aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN) (<5 × ULN in the case of liver metastases);
    - bilirubin ≤1.5 × ULN (<2 × ULN in case of liver metastases);
    c. Renal function: serum creatinine <1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft and Gault) for serum creatinine ≥1.5x ULN.
    8) Contraceptives measures:
    a.Women of childbearing potential must:
    i.have a negative pregnancy test within 1 week before first dose of study drug
    ii.use highly effective method(s) of birth control consistently and correctly during the study and for at least 5 months after the last dose of study drug
    iii.agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 5 months after the last dose of study
    iv.agree to no plan to breastfeed and no plan to become pregnant during the study and for at least 5 months after the last dose of study drug.
    b.Males who are sexually active must:
    i.agree to use a condom with spermicidal foam/gel/film/cream/suppository during the study and for at least 5 months after the last dose of study drug
    ii.agree to not donate sperm during the study and for at least 5 months after the last dose of study drug
    iii.no plan to father a child during the study or within 5 months after the last dose of study drug.
    9) Women must not be breastfeeding
    10) At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
    11) Patients must have no available standard of care for their disease, as determined by the treating Investigator
    12) Patients in the ICT01 Combination arms must meet the eligibility criteria in the approved package labeling of pembrolizumab and meet the following conditions:
    a. Must not be first-line patients (i.e., must meet Inclusion Criteria #11)
    b. Must not have any history or ongoing interstitial lung disease
    c. Must not have undergone prior anterior organ transplantation, including allograft stem cell transplantation

    For Part 2, Group D and E:
    13) Replaces inclusion criterion # 3: Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer including:
    a. Group D: persistent or recurrent epithelial ovarian cancer, primary fallopian or primary peritoneal cancer; failed at least 1 prior systemic platinum-containing regimen
    b. Group E: metastatic or unresectable, recurrent HNSCC; failed at least 1 prior systemic regimen
    14) Replaces inclusion criterion #11: Patients must have received at least one line of treatment for their cancer prior to enrolling on the study
    15) Circulating g9d2 T cell count ≥ 20 000 cells/mL of blood during screening
    E.4Principal exclusion criteria
    The following criteria must be checked over the screening period and at baseline. If ANY exclusion criterion applies, the subject must not be included in the study:
    1) Any malignancy of γ9δ2 T cell origin
    2) Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment (does not apply to patients receiving pembrolizumab for the combination arms)
    3) Treatment with investigational drugs within 28 days before study treatment
    4) Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or equivalent, for the last 28 days and ongoing
    5) Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement
    6) Ongoing immune-related adverse events (irAEs) and/or AEs ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
    7) Within 4 weeks of major surgery
    8) Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
    9) Primary or secondary immune deficiency
    10) Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
    11) Known/suspected hypersensitivity against ICT01, human or humanized IgGs, PD-1/PD-L1 blockers or their ingredients
    12) Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
    13) Clinically significant cardiac disease including heart failure (New York Heart Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year before study entry
    14) Dementia or altered mental status that would prohibit informed consent
    15) Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator
    16) Active drug or alcohol abuse as assessed by the Investigator
    17) Patients with uncontrolled and symptomatic brain metastases. Patient with asymptomatic brain metastases are allowed provided they are stable and off therapeutic steroids for at least 4 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1. The primary endpoint of safety and tolerability will be evaluated in this study by the incidence, severity, and relationship of TEAEs, SAEs, TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations (Key secondary endpoint in Part 2).

    Part 2. Disease Control Rate (DCR) that includes clinical response
    criteria as per RECIST, RECIL or as per disease-specific standards
    criteria as per RECIST, RECIL or as per disease-specific standards for the recovery (CRi) + Partial Response/Remission (PR) + Stable Disease.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On-going throughout the duration of the study
    E.5.2Secondary end point(s)
    In Parts 1 and 2, the PK parameters of ICT01 (including Cmax, AUC,
    t1/2, clearance) will be calculated by dose level. Likewise, the PD
    activity of ICT01 (by dose and patient population) will include the
    change from baseline in counts and activation status of Vγ9Vδ2 T cells
    and other immune cells in the peripheral blood, peripheral blood
    mononuclear cells (PBMCs) and tumor biopsies, circulating cytokine
    levels (including IFN gamma, TNF alpha, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-
    10, IL-17a and MCP-1), and expression of PD-L1, PD-1 and other
    immune cell markers in tumor biopsies and PBMCs.

    Baseline BTN3A expression and gamma delta T cells from tumor
    biopsies, and baseline gamma delta T cells and BTN3A expression in the
    circulation will be characterized and used as covariates for the PD and
    clinical response analyses to determine if they have utility for selecting
    patients for Part 2, future studies and as part of the potential companion
    diagnostic strategy.

    The primary PD activity measure to determine an active dose level of
    ICT01 will be a decrease from baseline and an increase in activation of
    circulating gamma delta T cells, as measured by flow cytometry.
    In Part 1 the preliminary anti-tumor activity endpoint will be the DCR
    and ORR as per RECIST, RECIL or as per disease-specific standards in the
    hematologic indications (e.g., Cheson/IWG Criteria for AML). The
    immunotherapy Response Evaluation Criteria In Solid Tumors (iRECIST
    (will be considered exploratory.

    In Part 2, key secondary endpoints include the safety and tolerability,
    time to progression (TTP),progression-free survival (PFS) and ORR as per RECIST, RECIL or as per disease-specific standards for the hematologic malignancies (e.g., Cheson/IWG Criteria for AML).
    E.5.2.1Timepoint(s) of evaluation of this end point
    On-going throughout the duration of 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 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 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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    France
    Germany
    Spain
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 309
    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)
    Normal treatment
    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 Decision2020-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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