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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-001748-36
    Sponsor's Protocol Code Number:GCT3013-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-07-09
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-001748-36
    A.3Full title of the trial
    A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    First-in-Human (FIH) Trial in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
    A.4.1Sponsor's protocol code numberGCT3013-01
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post codeDK- 1560
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@genmab.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 nameepcoritamab
    D.3.2Product code DuoBody-CD3xCD20
    D.3.4Pharmaceutical form Concentrate 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 INN.
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codeGEN3013 (DuoBody®-CD3xCD20)
    D.3.9.3Other descriptive nameGEN3013
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN.
    D.3.9.1CAS number 2134641-34-0
    D.3.9.3Other descriptive nameGEN3013
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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, progressive and/or refractory mature B-cell lymphoma
    Patients with:
    - Diffuse large B-cell lymphoma – de novo or transformed
    - High-grade B-cell lymphoma
    - Primary mediastinal large B-cell lymphoma
    - Follicular lymphoma
    - Mantle cell lymphoma
    - Small lymphocytic lymphoma
    - Marginal zone lymphoma (nodal, extranodal or mucosa
    associated)
    E.1.1.1Medical condition in easily understood language
    Lymphoma of B-cell origin
    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 PT
    E.1.2Classification code 10003903
    E.1.2Term B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Escalation Phase:
    - Determine maximum tolerated dose and recommended phase 2 dose

    Expansion Phase:
    - To evaluate clinical efficacy as determined by Lugano criteria

    Optimization part:
    - To determine whether an alternative priming/intermediate dose regimen may reduce CRS risk
    E.2.2Secondary objectives of the trial
    Escalation Phase:
    - Establish tolerability of epcoritamab
    - Establish PK profile after single and multiple doses
    - Evaluate immunogenicity
    - Evaluate anti-lymphoma activity

    Expansion and Optimization Part:
    - To further evaluate clinical efficacy as determined by Lugano criteria
    - To evaluate clinical efficacy as determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
    - To evaluate anti-lymphoma activity as determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
    - To further evaluate clinical efficacy
    - To evaluate MRD status as a clinical efficacy endpoint
    - To evaluate safety and tolerability of epcoritamab
    - To evaluate the PK and immunogenicity of epcoritamab
    - To evaluate patient-reported outcomes (PROs) related to lymphoma symptoms
    -To evaluate safety and tolerability of alternative priming/intermediate dosing regimens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be 18 years of age or older (for expansion: In countries where the legal age is 21 years of age; only patients 21 years of age or older are eligible)
    2. Documented CD20+ mature non-Hodgkin B-cell lymphoma according to WHO classification
    3. Relapsed, progressive and/or refractory disease (Cheson et al., 2007) following treatment with an anti-CD20 monoclonal antibody
    4. Patients must have received at least 2 prior lines of therapy
    5. Patients must have measurable disease by imaging
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
    7. For the optimization part, patients must have R/R DLBCL, or FL grades 1-3A, or MCL (according to cohort).
    E.4Principal exclusion criteria
    1. Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
    2. AST, and/or ALT > 3 x upper limit of normal
    3. Total bilirubin > 1.5 x upper limit of normal
    4. Creatinine clearance < 45 mL/min
    5. Known clinically significant cardiac disease, including:
    a. Onset of unstable angina pectoris within 6 months of signing ICF
    b. Acute myocardial infarction within 6 months of signing ICF
    c. Congestive heart failure (grade III or IV as classified by the New York Heart Association and/or known decrease ejection fraction of < 45%
    6. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrolment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection.
    7. Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue
    8. Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR positive) infection. Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy.
    9. Known human immunodeficiency virus (HIV) infection
    10. Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
    11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first GEN3013 administration
    12. Autologous HSCT within 100 days prior to first GEN3013 administration, or any prior allogeneic HSCT or solid organ transplantation
    13. Contraindication to all uric acid lowering agents
    E.5 End points
    E.5.1Primary end point(s)
    Escalation End Points:
    - Dose limiting toxicity
    - Adverse events

    Expansion End Points:
    - Overall response rate (ORR) determined by Lugano criteria as assessed by independent review committee (IRC)

    Optimization End Points:
    - Adverse events; Rating of ≥ Grade 2 CRS events
    E.5.1.1Timepoint(s) of evaluation of this end point
    - DLT evaluation period is defined as the first 4 weeks, i.e. 28 days after the first administration of GEN3013.
    - AE evaluation will be done at each visit during the entire study
    - Rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab
    E.5.2Secondary end point(s)
    Escalation End Points:
    - Cytokine measures
    - Laboratory parameters (biochemistry, hematology including immunophenotyping for absolute T-cell and B-cell counts as well as T-cell activation and exhaustion markers)
    - PK parameters (clearance, volume of distribution and area-under-the concentration- time curve (AUC0-Clast and AUC0-∞), maximum concentration (Cmax), time of Cmax (Tmax), pre dose values, and half-life)
    - Immunogenicity of GEN3013
    - Anti-lymphoma activity, i.e. resolution of constitutional symptoms, reduction in tumor size, objective and best response
    - Duration of response
    - Progression free survival
    - Time to next anti-lymphoma therapy
    - Overall survival

    Expansion and Optimization End Points:
    - Duration of response (DOR) determined by Lugano criteria as assessed by IRC
    - Complete response (CR) rate determined by Lugano criteria as assessed by IRC
    - Duration of CR (DoCR) by Lugano criteria as assessed by IRC
    - Progression-free survival (PFS) determined by Lugano criteria as assessed by IRC
    - Time to response (TTR) determined by Lugano criteria as assessed by IRC
    - Objective and best response rate determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) as assessed by IRC
    - PFS determined by LYRIC as assessed by IRC
    - DOR determined by LYRIC as assessed by IRC
    - DoCR determined by LYRIC as assessed by IRC
    - TTR determined by LYRIC as assessed by IRC
    - Overall survival (OS)
    - Time to next (anti-lymphoma) therapy (TTNT)
    - Rate of MRD negativity
    - MRD status by detection of cancer cell gene sequences
    - Safety (i.e., adverse events, laboratory parameters [biochemistry, hematology including immunophenotyping for absolute T-cell and B-cell counts as well as T-cell activation and exhaustion markers], hospitalizations, and cytokine measures)
    - PK parameters (clearance, volume of distribution, Cmax, Tmax, trough concentrations, and half-life) and incidence of ADAs to GEN3013
    - Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)
    - Rate of ≥ Grade 2 CRS events and all grade CRS events following first full dose Rate of ≥ Grade 2 CRS events and all grade CRS events overall
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout 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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Australia
    Canada
    Korea, Republic of
    Singapore
    United States
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    United Kingdom
    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
    The trial is considered completed with the last safety follow-up visit (4 weeks after last dose) for the last patient participating in the trial. The trial will run for a maximum of 5 years after the last patient’s first treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    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: 353
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 353
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 475
    F.4.2.2In the whole clinical trial 706
    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 no longer in the trial, further treatment is at the discretion of the patient's doctor.
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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
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