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    Summary
    EudraCT Number:2017-001394-16
    Sponsor's Protocol Code Number:GCT1029-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-01
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-001394-16
    A.3Full title of the trial
    First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumors
    Primer ensayo en humanos, abierto, de aumento escalonado de la dosis con cohortes de ampliación para evaluar la seguridad de GEN1029 en pacientes con tumores sólidos malignos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumors
    Primer ensayo en humanos, abierto, de aumento escalonado de la dosis con cohortes de ampliación para evaluar la seguridad de GEN1029 en pacientes con tumores sólidos malignos
    A.3.2Name or abbreviated title of the trial where available
    GEN1029 Safety Trial in Patients With Malignant Solid Tumors
    Ensayo sobre la seguridad de GEN1029 en pacientes con tumores sólidos malignos.
    A.4.1Sponsor's protocol code numberGCT1029-01
    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 B.V.
    B.1.3.4CountryNetherlands
    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 B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab B.V.
    B.5.2Functional name of contact pointClinica Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressYalelaan 60
    B.5.3.2Town/ cityCM Utrecht
    B.5.3.3Post code3584
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+34916307447
    B.5.6E-mailregulatory@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 Yes
    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.3.2Product code GEN1029
    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 2109730-69-8
    D.3.9.2Current sponsor code1029-01
    D.3.9.3Other descriptive nameHexabody-DR5-01, DS-1029-01
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot issued
    D.3.9.1CAS number 2109731-10-2
    D.3.9.2Current sponsor code1029-05
    D.3.9.3Other descriptive nameHexabody-DR5-05, DS-1029-05
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 advanced and/or metastatic colorectal cancer (CRC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), gastric (incl. esophagogastric junction) cancer, pancreatic cancer or urothelial cancer.
    Tumores sólidos malignos:
    pacientes con cáncer colorrectal avanzado o metastásico (CCR), carcinoma de pulmón no microcítico (CPNM), cáncer de mama triple negativo (CMTN), carcinoma de células renales (CCR), cáncer gástrico (inc. de la unión gastroesofágica), cáncer pancreático o cáncer urotelial
    E.1.1.1Medical condition in easily understood language
    advanced and/or metastatic colorectal cancer, non-small cell lung cancer, triple negative breast cancer, renal cell carcinoma, gastric cancer, pancreatic cancer, urothelial cancer.
    cáncer colorrectal avanzado y / o metastásico, cáncer de pulmón no microcítico, cáncer de mama triple negativo, carcinoma de células renales, cáncer gástrico, cáncer de páncreas, cáncer urotelial.
    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 MTD and/or the recommended Phase 2 dose(s) (RP2D)
    - Establish the safety profile of GEN1029
    • Determinar la dosis máxima tolerada (DMT) o las dosis recomendadas para la fase II (DRFII)
    • Determinar el perfil de seguridad de GEN1029
    E.2.2Secondary objectives of the trial
    - Establish the PK profile and evaluate immunogenicity of GEN1029 after single and multiple infusions
    - Evaluate the anti-tumor activity of GEN1029
    • Determinar el perfil de farmacocinética (FC) y evaluar la inmunogenia de GEN1029 tras infusiones únicas y múltiples

    • Evaluar la actividad antineoplásica de GEN1029
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with advanced and/or metastatic cancer who have no available standard therapy or who are not candidates for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1029 may be beneficial.
    - Patient must be ≥ 18 years of age
    - Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
    - Have an acceptable hematological status
    - Have an acceptable renal function
    - Have an acceptable liver function
    - Have an Eastern Cooperative Oncology Group performance status of 0 or 1
    - Body weight ≥ 40kg
    - Patients, both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after the last infusion of IMP
    • Pacientes con CCR, CPNM, CMTN, CCR, cáncer gástrico, pancreático o urotelial (inc. de la unión gastroesofágica) avanzado o metastásico que no disponen de tratamiento de referencia o que no son candidatos para el tratamiento de referencia disponible y para los que podría ser beneficioso el tratamiento con GEN1029, en opinión del investigador.
    • El paciente debe tener al menos 18 años de edad
    • Los pacientes deben tener una enfermedad mensurable según los Criterios de evaluación de la respuesta en tumores sólidos (Response Evaluation Criteria In Solid Tumors) versión 1.1
    • Presentan un estado hematológico aceptable
    • Presentan una función renal aceptable
    • Presentan una función hepática aceptable
    • Presentan un estado funcional del Grupo Oncológico Cooperativo de la Costa Este de los EE. UU. (ECOG) de 0 o 1
    • Peso corporal ≥40 kg
    • Los pacientes, tanto mujeres como hombres, en edad fértil o potencial reproductivo deben aceptar el uso de anticonceptivos adecuados de la visita de detección hasta seis meses después de la última infusión de IMP.
    E.4Principal exclusion criteria
    - Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first IMP administration
    - Have clinically significant cardiac disease
    - Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management
    - Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
    - Have received a cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first IMP administration
    - History of ≥ grade 3 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
    - Radiotherapy within 14 days prior to first IMP administration
    - Any prior therapy with a compound targeting DR4 or DR5
    - History of chronic liver disease or evidence of hepatic cirrhosis
    • Flebotrombosis profunda aguda o embolia pulmonar clínicamente significativa, inestable durante al menos 8 semanas antes de la primera administración del MI
    • Presentan una enfermedad cardíaca clínicamente significativa
    • Hipertensión no controlada definida como presión arterial sistólica ≥160 mmHg o presión arterial diastólica ≥100 mmHg, a pesar de un abordaje médico óptimo
    • Antecedentes de malformación arteriovenosa intracerebral, aneurisma cerebral, metástasis cerebral nueva (de menos de 6 meses de antigüedad) o progresiva o con accidente cerebrovascular
    • Antecedentes de aloinjertos en órganos (excepto en el caso de trasplante de córnea) o autotrasplante o alotrasplante de médula ósea o rescate con células madre en los 3 meses previos a la primera dosis del MI
    • Haber recibido una dosis acumulada de corticoesteroides ≥150 mg de prednisona (o dosis equivalentes de corticoesteroides) en las dos semanas previas a la primera administración del MI
    • Antecedentes de reacciones alérgicas de grado ≥3 al tratamiento con anticuerpos monoclonales, así como alergia conocida o presunta o intolerancia a algún fármaco administrado durante este ensayo
    • Radioterapia en los 14 días previos a la primera administración del MI
    • Tratamiento previo con un compuesto que ataque al DR4 o DR5
    • Historial de enfermedad hepática crónica o evidencia de cirrosis hepática
    E.5 End points
    E.5.1Primary end point(s)
    - Dose limiting Toxicities (DLTs)
    - Adverse events (AEs) and safety laboratory parameters (hematology and biochemistry)
    • Toxicidades limitantes de la dosis (TLD)
    • Acontecimientos adversos (AA) y parámetros analíticos de seguridad (hematología y bioquímica)
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLTs: dose limiting toxicities will be collected for the first two cycles i.e. DLT period of 28 days.
    AEs: screening; Day 1, 2, 8 during Cycles 1-3; Days 1, 8 during subsequent Cycles (4-PD); EoT; 4, 13, 26, 39, 52 Weeks after last dosing.
    TLDs se recogerán las toxicidades limitantes de la dosis durante los primeros dos ciclos, es decir, el período de TLDde 28 días.
    AEs: selección; Día 1, 2, 8 durante los Ciclos 1-3; Días 1, 8 durante ciclos posteriores (4-PD); EoT; 4, 13, 26, 39, 52 semanas después de la última dosificación.
    E.5.2Secondary end point(s)
    - PK parameters of GEN1029
    - Immunogenicity of GEN1029
    - Anti-tumor activity measured by tumor shrinkage
    - Objective Response, Progression-Free Survival (PFS), Overall Survival
    (OS) and Duration of Response (DoR)
    • Parámetros de FC de GEN1029)
    • Inmunogenia de GEN1029
    • Actividad antineoplásica medida mediante la reducción del tumor.
    • Respuesta objetiva, supervivencia sin progresión (SSP), supervivencia global (SG) y duración de la respuesta (DR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the entire study
    Durante todo el estudio
    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 Yes
    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 Yes
    E.7.1.3.1Other trial type description
    Phase I/II
    Fase I/ II.
    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 trial1
    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 No
    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
    Spain
    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 with the last safety follow-up visit (30 days after last dose) for the last subject participating in the trial.
    El ensayo se considera completado con la última visita de seguimiento de seguridad (30 días después de la última dosis) para el último sujeto que participó en el ensayo.
    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: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 206
    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)
    None. When a patient is no longer in the trial, further treatment is at the discretion of the patient's doctor.
    Ninguna. Cuando un paciente ya no está en el ensayo, el tratamiento adicional está en el criterio del médico del paciente.
    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 Decision2018-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-10-04
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