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    Summary
    EudraCT Number:2021-005110-34
    Sponsor's Protocol Code Number:ICT01-102
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-13
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-005110-34
    A.3Full title of the trial
    A two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 in combination with low-dose subcutaneous interleukin-2 in patients with advanced solid tumors (EVICTION-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ICT01 in combination with IL-2 in patients with advanced solid tumors
    A.4.1Sponsor's protocol code numberICT01-102
    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/ cityMarseille
    B.5.3.3Post code13009
    B.5.3.4CountryFrance
    B.5.4Telephone number0033698465644
    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.3.9.4EV Substance CodeSUB203793
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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.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 Yes
    D.2.1.1.1Trade name PROLEUKIN®
    D.2.1.1.2Name of the Marketing Authorisation holderClinigen Healthcare Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameproleukin
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALDESLEUKIN
    D.3.9.1CAS number 110942-02-4
    D.3.9.4EV Substance CodeSUB05303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22
    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 patients with advanced solid tumors : metastatic colorectal cancer (CRC) or metastatic ovarian cancer or metastatic castration-resistant prostate cancer (mCRPC) or metastatic pancreatic ductal adenocarcinoma (PDAC)
    E.1.1.1Medical condition in easily understood language
    Relapsed/refractory patients with metastatic cancer : colorectal or ovarian or prostate or pancreatic ductal adenocarcinoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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 PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    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 10076506
    E.1.2Term Castration-resistant prostate cancer
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    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 I
    Characterize the overall safety and tolerability profile of a range of intravenous (IV) doses of ICT01 in combination with low-dose subcutaneous (LDSC) IL-2 in patients with advanced solid tumors.
    Part II
    Characterize the preliminary antitumor activity of IV ICT01 in combination with LDSC IL-2 in patients with a specific solid tumor indication (up to 2 indications for Part 2 will be determined after Part 1).
    E.2.2Secondary objectives of the trial
    Part I
    1. Characterize the pharmacodynamic activity of ICT01 in combination with LDSC IL-2 to increase the number of γ9δ2-T cells in the blood and tumors of patients with advanced solid tumors.
    2. Characterize the preliminary anti-tumor activity of a range of IV doses of ICT01 in combination with LDSC IL-2 in patients with advanced solid tumors.
    Part II
    1. Characterize the overall safety and tolerability of IV ICT01 in combination with LDSC IL-2 in patients with a specific solid tumor indication.
    2. Characterize the pharmacodynamic activity of ICT01 in combination with LDSC IL-2 to increase the number of γ9δ2-T cells in the blood and tumors of patients with a specific solid tumor indication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Part 1
    The following criteria must be checked during the screening period and at baseline. ALL inclusion criteria must be met to include the subject in the study:
    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 who have failed at least 2 lines of systemic therapy or who failed first line therapy and are intolerant of or have a contraindication to the standard second line of therapy with histologically or cytologically confirmed diagnosis of:
    a. metastatic colorectal cancer (CRC)
    b. metastatic ovarian cancer
    c. metastatic castration-resistant prostate cancer (mCRPC)
    d. metastatic pancreatic ductal adenocarcinoma (PDAC)
    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);
    - platelet count ≥100 × 109/L;
    - lymphocyte count ≥0.5 × 109/L;
    - absolute neutrophil count ≥1.0 × 109/L;
    - White Blood Count (WBC) ≥ 4 × 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) Pulse oximetry of 95% or higher at rest, unless patient has chronic lung disease where 90% or higher at rest is acceptable
    9) 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 4 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 4 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 4 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 4 months after the last dose of study drug
    ii. agree to not donate sperm during the study and for at least 4 months after the last dose of study drug
    iii. no plan to father a child during the study or within 4 months after the last dose of study drug.
    10) Women must not be breastfeeding
    11) At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)
    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 systemic anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment
    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) ≥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) Ongoing systemic autoimmune disease requiring systemic immunosuppressive therapy
    8) Primary or secondary immune deficiency
    9) Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
    10) Known/suspected hypersensitivity against ICT01, human or humanized IgGs, IL-2 (Proleukin®) or their ingredients
    11) Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
    12) 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
    13) Dementia or altered mental status that would prohibit informed consent
    14) Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator
    15) Active drug or alcohol abuse as assessed by the Investigator
    16) Patients with uncontrolled and symptomatic brain metastases or seizure disorders. 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 I
    The primary endpoint of safety and tolerability will be evaluated in this study by the incidence, severity, and relationship of TEAEs, SAEs, and TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations.
    Part II
    Primary endpoint: Disease control rate (DCR) comprising patients with stable disease, partial response or complete response per RECIST1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ongoing throughout the duration of the study
    E.5.2Secondary end point(s)
    Part I
    • PD endpoint will be the change from baseline in counts and activation status of γ9δ2 T cells in PBMCs and tumor biopsies.
    • The preliminary antitumor activity endpoint will be DCR as per RECIST. iRECIST will be considered exploratory and used for treatment decisions.
    Part II
    • The key secondary safety endpoint will be evaluated by incidence, severity, and relationship of TEAEs, SAEs, and TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations
    • The efficacy endpoint will be the Objective response rate, time to progression (TTP) and progression-free survival (PFS).
    • PD endpoint will be the change from baseline in counts and activation status of γ9δ2 T cells in PBMCs and tumor biopsies.
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    second clinical trial with ICT01
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Spain
    United Kingdom
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 10
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 30
    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 Decision2022-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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