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    Summary
    EudraCT Number:2018-003716-47
    Sponsor's Protocol Code Number:GCT1042-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-02
    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 number2018-003716-47
    A.3Full title of the trial
    A first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1042 in subjects with malignant solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GEN1042 safety trial in patients with malignant solid tumors
    A.4.1Sponsor's protocol code numberGCT1042-01
    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 code1560
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4533779678
    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- CD40xCD137
    D.3.2Product code GEN1042
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNGEN1042 (DuoBody-CD40x4-1BB)
    D.3.9.1CAS number 2253891-70-0
    D.3.9.2Current sponsor codeDuoBody-CD40xCD137
    D.3.9.3Other descriptive nameGEN1042
    D.3.9.4EV Substance CodeSUB195352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number03 to 800
    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:

    Patients with relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC) who are not anymore candidates for standard therapy

    E.1.1.1Medical condition in easily understood language
    patients with advanced and/or metastatic melanoma, non-small cell lung cancer, colorectal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    E.1.2System Organ Class 100000004864
    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 maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
    - Establish the safety profile of GEN1042
    E.2.2Secondary objectives of the trial
    - Establish the PK profile of GEN1042
    - Evaluate immunogenicity of GEN1042
    - Evaluate the anti-tumor activity of GEN1042
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Both Dose Escalation and Expansion
    • Subject must have measurable disease according to RECIST 1.1.
    • Subject must have Eastern Cooperative Oncology Group (ECOG) 0-1.
    • Subject must have adequate organ and bone marrow function as defined in protocol.
    For Dose Escalation:
    • Subjects must have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
    For Expansion:
    • Subjects must have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, CRC cancer who are not anymore candidates for standard therapy.
    E.4Principal exclusion criteria
    •Subject has uncontrolled intercurrent illness, including but not limited
    to:
    • Ongoing or active infection requiring intravenous treatment with antiinfective therapy that has been administered less than 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 1 year) evidence of significant autoimmune
    disease that required treatment with systemic immunosuppressive
    treatments, which may suggest risk for immune-related adverse events
    (irAEs).
    • Subjects with a history of grade 3 or higher irAEs that led to
    treatment discontinuation of a checkpoint inhibitor should be excluded.
    Subjects with irAEs below grade 3 that led to discontinuation should be
    discussed with the sponsor.
    • Subjects with a prior history of myositis, Guillain-Barré syndrome, or
    myasthenia gravis of any grade are excluded.
    • History of chronic liver disease or evidence of hepatic cirrhosis.
    • History of non-infectious pneumonitis that has required steroids or
    currently has pneumonitis.
    • History of 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 GEN1042.
    • Serious, non-healing wound, skin ulcer (of any grade), or bone
    fracture.
    • Any history of intracerebral arteriovenous malformation, cerebral
    aneurysm, new (younger than 6 months) or progressive brain
    metastases or stroke.
    • Prior therapy:
    • Radiotherapy: Radiotherapy within 14 days prior to first GEN1042
    administration. Palliative radiotherapy will be allowed.
    • Treatment with an anti-cancer agent (within 28 days or after at least
    4 half-lives of the drug, whichever is shorter), prior to GEN1042
    administration. Accepted exceptions are bisphosphonates (e.g.,
    pamidronate, zoledronic acid, etc.) and denosumab.
    • Toxicities from previous anti-cancer therapies that have not resolved
    to baseline levels or to grade 1 or less with the exception of alopecia,
    anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and
    peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and
    peripheral neuropathy must have recovered to ≤ grade 2.
    E.5 End points
    E.5.1Primary end point(s)
    - Dose-limiting toxicity (DLT)
    - Adverse events (AEs) and safety laboratory parameters
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLTs: dose limiting toxicities will be collected for the first cycle i.e. DLT period of 3 weeks (21 days).
    AEs: screening; Day 1, 2, 3, 8, 15 during Cycles 1-2; Days 1, 8, 15 during Cycles 3-6, Day 1 subsequent Cycles (7-PD); EoT; 4, 8, 12, subsequent
    every 12 (survival follow-up) Weeks after last dosing.
    E.5.2Secondary end point(s)
    - PK parameters
    - Anti-Drug Antibody (ADA) response
    - Anti-tumor activity, i.e., reduction in tumor size according to RECIST
    1.1:
    - Objective Response Rate (ORR)
    - Disease Control Rate (DCR)
    - Duration of Response (DoR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the entire 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 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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Denmark
    United Kingdom
    United States
    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 when the last subject dies or
    withdraws from the trial.
    However, maximal trial duration is 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 years3
    E.8.9.1In the Member State concerned months1
    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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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 state7
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 126
    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)
    Post trial treatment is at the discretion of the patient's doctor according to standard-of-care per country and site.
    The Sponsor will ensure post-trial treatment for ongoing trial participants with a potential treatment benefit of GEN1042.
    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 Decision2019-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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