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    Summary
    EudraCT Number:2020-003781-40
    Sponsor's Protocol Code Number:GCT3014-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-003781-40
    A.3Full title of the trial
    An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of GEN3014 in relapsed or refractory hematologic malignancies
    A.3.2Name or abbreviated title of the trial where available
    Phase 1/2 trial of GEN3014 in relapsed or refractory hematologic malignancies
    A.4.1Sponsor's protocol code numberGCT3014-01
    A.5.4Other Identifiers
    Name:INDNumber:146079
    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 US Inc
    B.5.2Functional name of contact pointSenior Clinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street Address777 Scudders Mill Road · Bldg. 2 
    B.5.3.2Town/ cityPlainsboro
    B.5.3.3Post codeNJ 08536
    B.5.3.4CountryUnited States
    B.5.4Telephone number+4570202728
    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 nameHexaBody®-CD38
    D.3.2Product code GEN3014
    D.3.4Pharmaceutical form Concentrate for 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 INNGEN3014
    D.3.9.1CAS number 2430792-01-9
    D.3.9.2Current sponsor codeHexaBody®-CD38
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 DARZALEX 1800 mg solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1153
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNDaratumumab
    D.3.9.1CAS number 945721-28-8
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman monoclonal antibody
    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 or Refractory Multiple Myeloma and Other Hematologic Malignancies
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
    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 10066481
    E.1.2Term Hematological malignancy
    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 10028228
    E.1.2Term Multiple myeloma
    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
    - Determine the RP2D and if reached, the MTD of GEN3014
    - Evaluate the safety and tolerability of GEN3014

    Please refer to the protocol section 2 (Tables 2-2 and 2-3) for the full list of main objectives for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively.
    E.2.2Secondary objectives of the trial
    - Characterize the PK properties of GEN3014
    - Evaluate immunogenicity
    - Assess the preliminary anti-tumor activity of GEN3014
    - Assess the clinical efficacy of GEN3014

    Please refer to the protocol section 2 (Tables 2-2 and 2-3) for the full list of secondary objectives for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be at least 18 years of age.
    2. Must sign an informed consent form (ICF) prior to any Screening procedures. Where required by local or country specific regulations, each subject must sign a separate ICF if he or she agrees to provide samples for genomic biomarker analysis (deoxyribonucleic acid [DNA] and ribonucleic acid [RNA]).
    3. Must have fresh bone marrow samples collected at Screening.
    4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2.
    5. Has acceptable laboratory test results during the Screening period
    6. A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3014 administration. Adequate contraception is defined as highly effective methods of contraception (refer to Appendix 10.4 for more information). In countries where 2 highly effective methods of contraception are required, both methods will be required for inclusion.
    7. A woman of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) at Screening.
    8. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014.
    9. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the trial and for 12 months after receiving the last dose of GEN3014.

    Specific Inclusion Criteria for RRMM:
    10. Must have documented multiple myeloma as defined by the criteria below and have evidence of disease progression on the most recent prior treatment regimen based on IMWG criteria:
    • Prior documentation of monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy-proven plasmacytoma and
    • Measurable disease at baseline as defined by any of the following:
    - IgG, IgA, IgD, or IgM myeloma: Serum M-protein level ≥0.5 g/dL (≥5 g/L) or urine M-protein level ≥200 mg/24 hours;
    or
    - Light chain myeloma: Serum Ig free light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
    11. For anti-CD38 mAb-naive RRMM Cohort: Subject received at least 3 prior lines of therapy including a PI and an IMiD in any order, or is double refractory to a PI and an IMiD; or subject received ≥ 2 prior lines of therapy if 1 of those lines included a combination of PI and IMiD. Note: Subjects should not have received any anti-CD38 antibody.
    12. For anti-CD38 mAb-treated RRMM Cohort: Subject has received at least 2 prior lines of therapy and must have discontinued daratumumab or isatuximab for at least 4 weeks prior to the first dose of GEN3014. Note: Subjects should not have received any other anti-CD38 antibody except daratumumab or isatuximab.
    13. Potassium level ≥3.0 mEq/L (≥3.0 mmol/L); or corrected serum calcium ≤14.0 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L).

    Specific Inclusion Criteria for R/R AML:
    14. Relapsed or refractory AML, both de novo or secondary except for acute promyelocytic leukemia (APL); or previously untreated subjects who are considered inappropriate candidates for the standard induction therapy. Note: Relapse is defined by BM blasts ≥5% in patients who have been in complete remission (CR) previously, or reappearance of blasts in the blood, or development of extramedullary AML. Refractory is defined as not being able to achieve a CR
    after the initial therapy.
    15. Subject with relapsed AML who received at least 2 prior therapies for AML with the exception of hydroxyurea.
    16. Subject with refractory AML who received at least 1 prior line of therapy for AML with the exception of hydroxyurea.
    17. Subject's life expectancy at Screening is judged to be at least 3 months.

    Please refer to Protocol sections 4.1.2 and 4.1.3 for the Inclusion Criteria for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H), respectively
    E.4Principal exclusion criteria
    1. Prior treatment with an anti-CD38 antibody except daratumumab or isatuximab. Note: Prior daratumumab or isatuximab exposure is allowed for anti-CD38 mAb-treated RRMM subjects in the Dose Escalation and anti-CD38 mAb-refractory RRMM Cohort in the Expansion.
    2. Treatment with an anti-cancer agent (eg, small molecule, antibody, CAR-T cell therapy), chemotherapy, radiation therapy, or major surgery within 2 weeks prior to the first dose of GEN3014.
    3. Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3014.
    4. Cumulative dose of corticosteroids more than the equivalent of ≥140 mg of prednisone within 2-week period before the first dose of GEN3014.
    5. Has clinically significant cardiac disease, including:
    • Myocardial infarction within 1 year prior to the first dose of GEN3014, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV [see Appendix 10.6]) cardiac arrhythmia (CTCAE v5.0 grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities.
    • Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) >480 msec.
    6. Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
    7. Primary central nervous system (CNS) tumor or known CNS involvement at Screening.
    8. Has known history/positive serology for hepatitis B (unless immune due to vaccination or resolved natural infection or unless passive immunization due to Ig therapy):
    • Positive test for antibodies to the hepatitis B core antigen (anti-HBc) and
    • Negative test for antibodies to the hepatitis B surface antigen (anti-HBs).
    9. Known medical history or ongoing hepatitis C infection that has not been cured.
    10. Known history of seropositivity of human immunodeficiency virus (HIV).
    11. Currently receiving any other investigational agents.
    12. A woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of GEN3014.
    13. A man who plans to father a child while enrolled in this trial or within 12 months after the last dose of GEN3014.

    Specific Exclusion Criteria for RRMM:
    14. Prior allogeneic HSCT.
    15. Autologous HSCT within 3 months of the first dose of GEN3014.

    Specific Exclusion Criteria for R/R AML:
    16. <5% blasts in blood or bone marrow at Screening.
    17. Prior autologous HSCT..
    18. Allogenic HSCT within 3 months of the first dose of GEN3014.
    19. Active graft-versus-host-disease requiring immunosuppressive treatment. Any immunosuppressive medication (eg, calcineurin inhibitors) must be stopped ≥4 weeks prior to the first dose of GEN3014.
    Additional Criterion for All Subjects
    • History of allergic reactions attributed to compounds of similar active substance or excipients.
    • Has known past or current malignancy other than inclusion diagnosis, except for:
    a. Cervical carcinoma of Stage 1B or less.
    b. Non-invasive basal cell or squamous cell skin carcinoma.
    c. Non-invasive, superficial bladder cancer.
    d. Prostate cancer with a current PSA level <0.1 ng/mL.
    e. Any curable cancer with a CR of >2 years duration.

    Please refer to the protocol section 4.2.2 for the full list of Exclusion criteria for the Expansion Part B (Randomized H2H).
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of DLTs
    - Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs, electrocardiograms (ECGs)
    - Tolerability: Dose interruptions, delay, and dose intensity.

    Please refer to the protocol section 2 (Tables 2-2 and 2-3) for the full list of primary endpoints for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to Protocol
    E.5.2Secondary end point(s)
    • Noncompartmental PK parameters (if feasible):
    o Maximum concentration (Cmax)
    o Time to Cmax (Tmax)
    o Predose concentration (Ctrough)
    o Area under the concentration-time curve from time zero to last quantifiable sample (AUC0-last) and from time zero to 168 h (AUC0-168h)
    o Accumulation ratios in Cmax (RA,Cmax) and AUC (RA,AUC]
    • In addition, a population PK modeling approach may be employed
    • Anti-GEN3014 antibodies
    • Objective response rate (ORR)
    • Clinical benefit rate (CBR)
    • Duration of response (DOR)
    • Time-to-response (TTR)
    • Progression-free survival (PFS)
    • Overall survival (OS)

    Please refer to the protocol section 2 (Tables 2-2 and 2-3) for the full list of secondary endpoints for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    According 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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and Immunogenicity
    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 Yes
    E.7.1.3.1Other trial type description
    Dose escalation
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Randomized for Expansion Part B (Randomized H2H)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA23
    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
    Malaysia
    New Zealand
    Philippines
    Bosnia and Herzegovina
    North Macedonia
    Moldova, Republic of
    Ukraine
    Australia
    Georgia
    Korea, Republic of
    Serbia
    United States
    Czechia
    Denmark
    Greece
    Hungary
    Poland
    Spain
    Sweden
    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 years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 61
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 123
    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)
    Not Applicable
    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 Decision2020-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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