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    Summary
    EudraCT Number:2021-001928-17
    Sponsor's Protocol Code Number:GCT1046-04
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001928-17
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Recurrent Non-Small Cell Lung
    cancer
    A.3.2Name or abbreviated title of the trial where available
    Safety and efficacy of GEN1046 in patients with non-small cell lung cancer
    A.4.1Sponsor's protocol code numberGCT1046-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05117242
    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 AddressCarl Jacobsens Vej 30
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number+457020 2728
    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 nameDuoBody-PD-L1x4-1BB
    D.3.2Product code GEN1046
    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 INNNot issued
    D.3.9.1CAS number 2253937-12-9
    D.3.9.2Current sponsor codeGEN1046-DS
    D.3.9.3Other descriptive nameBisG1, anti-(human Cluster of Differentiation 274) (human 7717b gamma1-chain), disulfide with human 7717b lambda-chain, dimer / Immunoglobulin G1, anti-(human Cluster of Differentiation 137) (human 7729a gamma1-chain), disulfide with human 7729a kappa-chain, dimer
    D.3.9.4EV Substance CodeSUB195353
    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 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 KEYTRUDA 25 mg/mL concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKeytruda
    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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Malignant Solid Tumors - Non Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Locally advanced or metastatic non-small cell lung cancer in patients who failed a first line of treatment.
    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 PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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
    Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLC
    E.2.2Secondary objectives of the trial
    • Evaluate time to onset and durability of the anti-tumor response of GEN1046 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLC
    • Evaluate the clinical benefit of GEN1046 as monotherapy and in combination with pembrolizumab
    • Assess safety and tolerability of GEN1046 as monotherapy and in combination with pembrolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must sign an informed consent form (ICF).
    2. Subject must be at least 18 years of age on the day of signing the ICF
    3. Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease.
    4. Subject must have a tumor PD‑L1 expression result available prior to C1D1 demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a sponsor designated central laboratory using the Dako PD‑L1 IHC 22C3 pharmDx assay (TPS≥1%), or per site local assessment with the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%) or the VENTANA PD-L1 (SP263) assay (TC ≥1%) adhering to the manufacturer’s instructions.
    Note: Local PD-L1 result needs to be performed on fresh tumor tissue (obtained within 3 months prior to enrollment and after failure/stop of last prior treatment) or, if not feasible, archival tissue (obtained within 12 months prior to enrollment).
    5. Subject must have measurable disease per RECIST v1.1 as assessed by the investigator.
    6. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
    7. Subject must have life expectancy of at least 3 months.
    8. Subject must have adequate organ and bone marrow function.
    E.4Principal exclusion criteria
    1. Documentation of known EGFR sensitizing mutations, KRAS, RET, ROS1, or BRAF mutations, NTRK gene infusions, RET rearrangement, ALK gene rearrangements, high-level MET amplification, or METex 14 skipping.
    2. Subject has been exposed to any of the following therapies:
    - Treatment with an anti-cancer agent within 28 days prior to GEN1046 administration.
    - Any investigational agent for the treatment of stage 4 NSCLC.
    - Radiotherapy within 14 days prior to first GEN1046 administration - Radiotherapy within 14 days prior to first GEN1046 administration or received lung radiation therapy of >30 Gy within 6 months of the first dose of trial treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
    - Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone >10 mg daily or a cumulative dose >150 mg prednisone within 14 days before the first GEN1046 administration.
    3. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
    4. Subject has any of the following:
    - Ongoing or active infection requiring intravenous treatment with antiinfective therapy that has been administered <2 weeks prior to first dose.
    - Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia.
    - Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management.
    - Ongoing or recent (within 6 months) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
    5. Subject has a known history of any of the following:
    - Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment.
    - Myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade.
    - Liver disease (eg, alcoholic hepatitis or non-alcoholic steatohepatitis, drug-related or autoimmune hepatitis, or evidence of hepatic cirrhosis).
    - Organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1046.
    - Grade 3 or higher allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial.
    For further information, please refer to Clinical Trial Protocol.
    E.5 End points
    E.5.1Primary end point(s)
    • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR is defined as the proportion of subjects with a confirmed response of partial response (PR)
    or complete response (CR) according to RECIST v1.1 criteria. The minimum time from first infusion of trial drug required to qualify for an assessment of stable disease (SD) is 5 weeks, corresponding to the minimum planned time of the first imaging assessment.
    Disease will be evaluated per RECIST v1.1. CT with contrast (preferred) or MRI will be obtained at baseline before the first dose and 6, 12, 18, and 24 weeks (±7 days) after the first dose of trial medication, and thereafter, every 9 weeks (±7 days). CT or MRI will continue to be obtained until disease progression, start of subsequent anti-cancer therapy, withdrawal of consent, or death, whichever occurs first.
    E.5.2Secondary end point(s)
    • Duration of response (DOR) per RECIST v1.1
    • Time to response (TTR) per RECIST v1.1
    • Progression-free survival (PFS) per RECIST v1.1
    • Overall survival (OS)
    • Incidence and severity of AEs
    • Incidence and severity of laboratory abnormalities
    E.5.2.1Timepoint(s) of evaluation of this end point
    - DOR: DOR is defined for responders as the time from initial onset of response to first progression event, defined as radiographic progression or death.
    - TTR: Time to response (TTR) is defined as the time from first infusion of trial drug to onset of response.
    - PFS: PFS is defined as the time from first infusion of trial drug to first progression event, defined as radiographic progression or death.
    - OS: OS is defined as time from first infusion of trial drug to death due to any cause.
    - Safety, including AEs, physical examinations, Eastern Cooperative Oncology Group (ECOG)performance status (PS), vital signs, electrocardiograms, and laboratory values, will be monitored throughout the trial.
    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 Yes
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity, Biomarker Analyses, Health-related Quality of life
    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 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 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 trial3
    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 EEA41
    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
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    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
    The trial is considered completed when the last subject dies or withdraws from the trial. However, maximal trial duration is up to 3 years after the last subject’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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the subject (or representative) is unable to read/write, an impartial witness should be present for the entire informed consent process and should personally date and sign ICF after the oral consent of the subject (or representative) is obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 113
    F.4.2.2In the whole clinical trial 160
    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)
    The sponsor will make their best effort to provide post-trial access to GEN1046 for those subjects with a potential treatment benefit, in accordance with local laws and requirements.
    For subjects in Arms B and C, the continued access to trial treatment
    will end when a criterion for discontinuation is met or 35 (for Q3W dosing) /18 (for Q6W dosing) doses of pembrolizumab have been administered.
    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 Decision2022-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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