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    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
    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.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.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.5.4Telephone number33698 46 56 44
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 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
    Part 1
    Characterize the safety and tolerability of ICT01 intravenous (IV) as
    monotherapy, and in combination with pembrolizumab (Keytruda®) in
    patients with relapsed/refractory advanced solid tumors or hematologic

    Part 2
    Characterize the preliminary anti-tumor activity of ICT01 IV as
    monotherapy and in combination with pembrolizumab in patients with
    relapsed/refractory advanced solid tumors and in combination with
    venetoclax (VEN; Venclyxto®, Venclexta®)/ azacitidine (AZA; Vidaza®)
    in with newly diagnosed acute myeloid leukemia (AML)
    E.2.2Secondary objectives of the trial
    Part 1
    1.Determine the recommended ICT01 dose(s) for use as monotherapy
    and in combination with pembrolizumab.
    2. Characterize the pharmacokinetics (PK) of IV ICT01 administered 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. Determine the recommended ICT01 dose(s) for use in combination
    with VEN/AZA.
    2. Characterize the overall safety and tolerability of IV ICT01 as
    monotherapy, and in combination with pembrolizumab or VEN/AZA
    3.Characterize the PK of IV ICT01 administered as monotherapy and in
    combination with pembrolizumab or VEN/AZA.
    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 and Part2:
    1) Male or female aged ≥18 years
    2) Voluntarily signed written informed consent
    3) Patients with histologically or cytologically confirmed diagnosis of
    advanced cancer including:
    a.Group A: Relapsed/refractory advanced bladder, breast, colorectal,
    gastric, melanoma, ovarian, prostate and PDAC
    b.Group B: Relapsed/refractory advanced hematologic malignancies
    including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse
    large B cell lymphoma and follicular lymphoma
    c.Group C: Relapsed/refractory advanced melanoma, bladder, head and
    neck SCC, and non small cell lung cancer (approved indications in the US
    & EU for pembrolizumab)
    d.Group D: persistent or recurrent advanced epithelial ovarian cancer,
    primary fallopian or primary peritoneal cancer;
    e.Group E: mCRPC patients who failed prior androgen deprivation
    therapy. Patients may have also failed prior taxane therapy.
    f.Group F: Newly diagnosed AML, by WHO 2022 criteria, in patients who
    are indicated to start treatment with VEN/AZA
    g.Group G: metastatic or unresectable melanoma with primary
    resistance following at least 6 weeks of prior CPI treatment for advanced
    disease, defined as best response of progressive disease or SD of short
    duration (lasting less than 6 months),
    h.Group H: locally advanced or metastatic urothelial carcinoma who are
    not eligible for any platinum-containing chemotherapy, or who have
    disease progression during or following platinum-containing
    chemotherapy or within 12 months of neoadjuvant or adjuvant
    treatment with platinum-containing chemotherapy.
    i. Group I: metastatic or unresectable, recurrent HNSCC in patients who
    failed first-line immunotherapy or for whom immunotherapy was
    contraindicated, or in patients who failed 2 prior systemic regimens
    including an immunotherapy.
    4) Willingness to undergo Screening, baseline, and on-study tumor
    biopsies or BMAs, as applicable;
    5) ECOG performance status ≤ 1 (expect for Group F)
    6) Life expectancy > 3 months
    7)Clinical labs:
    a. Hematology:
    - Hemoglobin ≥8.5 g/dL
    - All Groups except Group B and F:
    • platelet count ≥75 × 109/L;
    • lymphocyte count ≥0.5 × 109/L;
    • absolute neutrophil count ≥1.0 × 109/L;
    b. Liver enzymes:
    - AST and 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
    8) Adequate Contraceptives measures for males and women of
    childbearing potential
    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)Part 1: Patients must have no available standard of care or available
    treatment with potential survival benefit for their disease, as determined
    by the treating Investigator
    12) in Groups C, G, H, and I must meet the eligibility criteria in the
    approved package labeling of pembrolizumab and meet the following
    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
    Part 2:
    13)Replaces inclusion criterion #11 (all groups excepeted group F):
    Patients must have received at least one line of treatment for their
    cancer prior to enrolling on the study
    14)Replaces inclusion criterion #11: Patients must be planned to start
    VEN/AZA as per label indication as described in inclusion criterion 3.f;
    Part 2 Group F
    14)Replaces inclusion criterion #11: Patients must be planned to start
    VEN/AZA as per label indication
    15)Replaces inclusion criterion #5: Participant must have an ECOG
    Performance status of 0 to 2 in the EU and UK
    16)Replaces inclusion criterion #7: Clinical labs:
    •abnormalities should be evaluated by the Investigator as acceptable
    and related to the underlying disease;
    •Other abnormalities should be evaluated by the investigator as
    acceptable and related to the underlying disease
    b.Liver enzymes:
    •Aspartate transaminase (AST) and alanine transaminase (ALT) (<5 ×
    ULN in the case of liver involvement);
    patients ≥ 75 years of age: ≤1.5 × ULN (<2 × ULN in case of liver
    patients ≥ 18 to 74 years of age: total bilirubin ≤ 3.0 × Upper Limit of
    Normal (ULN) in line with inclusion 3f.
    c.Renal function (EU and UK):
    •patients ≥ 75 years of age: serum creatinine <1.5 × ULN or creatinine
    clearance ≥50 mL/min (Cockroft and Gault) for serum creatinine ≥1.5x
    •patients ≥ 18 to 74 years of age creatinine clearance ≥ 30 mL/min in
    line with inclusion in line with inclusion 3f
    E.4Principal exclusion criteria
    The following criteria must be checked during 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
    3) Treatment with investigational drugs within 28 days before study
    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 lifethreatening
    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
    from previous therapies except vitiligo, stable neuropathy up to grade 2,
    hair loss, and stable endocrinopathies with substitutive hormone
    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), Patients positive for HIV can be
    eligible if cluster of differentiation (CD)4+ T-cell counts ≥350 cells and
    have no history of AIDS-defining opportunistic infections in the past 12
    months, as deemed appropriate by the Investigator;
    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
    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.
    Group F Specific Exclusion Criteria all above apply align with VIALE-A
    trial (DiNardo et al. 2020)
    18)Patients with t(15;17), t(8;21), inv(16), or t(16;16) karyotypic
    19)Participant has history of myeloproliferative neoplasm (MPN)
    including myelofibrosis, essential thrombocythemia, polycythemia vera,
    chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation
    and AML with BCR-ABL1 translocation.
    20) Patient has a white blood cell count >25 x 10⁹/L. In EU and
    UK:Hydroxyurea, and/or cytarabine (up to 1 g total) is permitted to
    meet this criterion.
    21)Patients with known symptomatic or uncontrolled CNS leukemia.
    22)Any previous or concomitant malignancy, except when the patient
    has completed definitive curative-intent treatment with chemotherapy
    and/or surgery and/or radiotherapy at least 3 months prior to
    enrollment. Patients having completed definitive treatment for following
    conditions may be eligible immediately after completion of definitive
    curative intent therapy, after healing of wounds, and no evidence of
    residual disease by examination, imaging, and/or cytology/pathology,
    e.g., non-melanoma skin cancers, or a carcinoma in-situ, e.g., ductal
    carcinoma in situ, urothelial cancer, cervical cancer, localized prostate
    cancer, pre-cancerous colon polyp, etc…
    23)Patients with contraindications to VEN or AZA according to
    prescribing information.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    -Incidence, severity (according to National Cancer Institute [NCI]-
    Common Terminology Criteria for Adverse Events [CTCAE] Version 5),
    and relationship to study treatment of treatment-emergent adverse
    events (TEAEs), serious adverse events (SAEs), and TEAEs leading to
    discontinuation of study treatment or treatment modifications;
    -Incidence and severity (according to NCI-CTCAE Version 5) of clinical
    laboratory abnormalities;
    -Clinically significant findings on vital signs, electrocardiograms (ECGs),
    and physical examinations.

    Part 2
    -DCR according to RECIST Version 1.1 for solid tumors (complete
    response [CR] + partial response [PR] + stable disease [SD]);
    -Complete remission rate (CRR) according to the European LeukemiaNet
    (ELN) 2022 criteria for AML (complete remission [CR] + CR with partial
    hematological recovery [CRh] + CR with incomplete hematological
    recovery [CRi] + morphologic leukemia-free state [MLFS]).
    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)
    Part 1:
    Incidence of dose-limiting toxicities (DLTs), other safety measures, and biomarker data.
    PK parameters of ICT01, including maximum serum drug concentration (Cmax), area under the concentration-time curve (AUC), elimination half-life (t1/2), clearance.
    Disease control rate (DCR) and objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST), immunotherapy RECIST (iRECIST), Response Evaluation Criteria In Lymphoma (RECIL), or as per disease-specific standards in other
    hematologic indications, as appropriate.

    Part 2:
    Incidence of DLTs, other safety measures, and biomarker data.
    Incidence, severity (according to CTCAE Version 5), and relationship of TEAEs, SAEs, and TEAEs leading to discontinuation of study treatment or treatment modifications;
    Incidence and severity (according to CTCAE Version 5) of clinical laboratory abnormalities;
    Clinically significant findings on vital signs, ECGs, and physical examinations.
    PK parameters of ICT01, including Cmax, AUC, t1/2, and clearance.
    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. 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
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 264
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 409
    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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