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    Summary
    EudraCT Number:2020-000845-15
    Sponsor's Protocol Code Number:GCT3013-02
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-11-10
    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 ConcernedFinland - Fimea
    A.2EudraCT number2020-000845-15
    A.3Full title of the trial
    A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    EPCORE™ NHL-2
    A.4.1Sponsor's protocol code numberGCT3013-02
    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.4.1Name of organisation providing supportGenmab US, Inc.
    B.4.2CountryUnited States
    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 code1560
    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 GEN3013
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNepcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.3Other descriptive nameGEN3013 (DuoBody®-CD3xCD20)
    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.3.11 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 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 GEN3013
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNepcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.3Other descriptive nameGEN3013 (DuoBody®-CD3xCD20)
    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
    B-cell Non-Hodgkin Lymphoma
    Diffuse large B-cell lymphoma
    Non-Hodgkin lymphoma
    Follicular lymphoma
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose Escalation Phase: Evaluate the safety and tolerability of epcoritamab in combination with other agents

    Expansion Phase:
    Arms 1-6 and 8-10: Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents
    Arm 7: Evaluate the safety and tolerability of epcoritamab following standard of care (SOC)
    E.2.2Secondary objectives of the trial
    Dose Escalation Phase:
    - Characterize the pharmacokinetic (PK) properties of epcoritamab
    - Evaluate pharmacodynamic markers linked to efficacy and mechanism of action of epcoritamab
    - Evaluate immunogenicity
    - Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents

    Expansion Phase:
    - Further assess the preliminary anti-tumor activity of epcoritamab in combination with other agents
    - Further evaluate the safety and tolerability of epcoritamab in combination with other agents
    - Characterize the PK properties of epcoritamab
    - To evaluate pharmacodynamic markers linked to efficacy and mechanism of action of epcoritamab
    - Evaluate immunogenicity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must sign an ICF
    2. At least 18 years of age
    3. Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
    4. ECOG PS score of 0, 1 or 2
    5. Acceptable organ function at screening
    6. CD20-positive NHL at most recent representative tumor biopsy
    7. If of childbearing potential subject must practicing a highly effective method of birth control
    8. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
    9. Life expectancy >2 months with SOC treatment.

    Arm 1: One of these confirmed histologies:
    - DLBCL, NOS
    - T-cell/histiocyte rich DLBCL
    - "double-hit" or "triple-hit" DLBCL
    - FL Grade 3B
    Arm 2 and Arm 9: R/R FL
    Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
    Arm 4 and Arm 10: One of these confirmed histologies and eligible for HDT-ASCT
    - DLBCL, NOS
    - - T-cell/histiocyte rich DLBCL
    - "double-hit" or "triple-hit" DLBCL
    - FL Grade 3B
    Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT
    - DLBCL, NOS
    - T-cell/histiocyte rich DLBCL
    - "double-hit" or "triple-hit" DLBCL
    - FL Grade 3B
    Arm 6: previously untreated CD20+ FL
    Arm 7: FL and in CR or PR per Lugano criteria following first-line or second-line treatment with SOC regiment and last dose of SOC within 6
    months prior to enrollment
    Arm 8: One of these confirmed histologies:
    - DLBCL, NOS
    - T-cell/histiocyte rich DLBCL
    - "double-hit" or "triple-hit" DLBCL
    -FL Grade 3B
    For Arm8, subjects must be ineligible to receive full-dose anthracycline
    (as part of R-CHOP) per eligibility criteria
    Arm 9: Must have received only 1 prior line of therapy. This first-line therapy must have included an anti-CD20 antibody in combination with chemotherapy. Progressed within 24 months of initiating first-line treatment
    E.4Principal exclusion criteria
    1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
    2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
    3. Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
    4. Clinically significant cardiovascular disease
    5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
    6. CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
    7. Active HBV or HBC (DNA PCR positive infection)
    8. Known history of seropositivity for human immunodeficiency virus
    (HIV)
    9. Active tuberculosis or history of completed treatment for active
    tuberculosis within the past 12 months
    10. Subject has current seizure disorder requiring anti-epileptic therapy
    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation Phase:
    - Incidence of dose-limiting toxicities
    - Incidence and severity of adverse events (AEs)
    - Incidence and severity of changes in laboratory values
    - Incidence of dose interruptions and delays

    Expansion Phase:
    Arms 1-6 and 8-10:
    - ORR determined by Lugano criteria
    Arm 7:
    - Incidence and severity of AEs
    - Incidence and severity of changes in laboratory values
    - Incidence of dose interruptions and delays
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT evaluation period is defined as the first 4 weeks, ie, 28 days after the first administration of epcoritamab.
    For the other end points, please refer to protocol
    E.5.2Secondary end point(s)
    Dose Escalation Phase:
    - PK parameters (clearance, volume of distribution, area under-the-concentration-time curve [AUC0-last and AUC0-∞], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and half-life)
    - Pharmacodynamic markers in blood samples and within tumor (on-treatment biopsy)
    - Incidence of anti-drug antibodies (ADAs) to epcoritamab
    - ORR determined by Lugano criteria
    - Duration of response (DOR) determined by Lugano criteria
    - Time to response (TTR) determined by Lugano criteria
    - Progression-free survival (PFS) determined by Lugano criteria
    - Overall survival (OS)
    - Time to next anti-lymphoma therapy (TTNT)
    - Rate and duration of minimal residual disease (MRD) negativity

    Expansion Phase:
    -DOR determined by Lugano criteria (Arms 1-6 and 8-10)
    -TTR determined by Lugano criteria (Arms 1-6 and 8-10)
    -PFS determined by Lugano criteria (Arms 1-6 and 8-10)
    -CR rate (Arm 1-10 except Arm 7 subjects in CR at baseline)
    -OS (Arms 1-10)
    -TTNT (Arms 1-10)
    -Rate and duration of MRD negativity (Arms 1-10)
    -Rate of conversion from MRD positivity to MRD negativity (Arm 7)
    -CR rate (Arm 7 subjects in PR at baseline)
    -TTCR (Arms 1-10, except Arm 7 subjects in CR at baseline)
    -DoCR (Arms 1-10)

    -Incidence and severity of AEs (Arms 1-6, and 8-10)
    -Incidence and severity of changes in laboratory values (Arms 1-6, and 8-10)
    -Incidence of dose interruptions and delays (Arms 1-6, and 8-10)

    -PK parameters

    -Pharmacodynamic markers in blood samples and within tumor (ontreatment biopsy)

    -Incidence of ADAs to epcoritamab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b
    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.8.2.4Number of treatment arms in the trial9
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    United States
    Belgium
    Czechia
    Denmark
    Finland
    France
    Italy
    Netherlands
    Norway
    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
    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: 331
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 331
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    elderly
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 339
    F.4.2.2In the whole clinical trial 662
    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 Decision2020-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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