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    Summary
    EudraCT Number:2021-002040-78
    Sponsor's Protocol Code Number:D8151C00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-002040-78
    A.3Full title of the trial
    A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination with Durvalumab and Chemotherapy in Participants with Locally Advanced or Metastatic Solid Tumours
    Estudio de fase II para evaluar la seguridad, farmacocinética y actividad clínica de AZD0171 en combinación con durvalumab y quimioterapia en participantes con tumores sólidos localmente avanzados o metastásicos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination with Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours
    Seguridad, farmacocinética y actividad clínica de AZD0171 en combinación con durvalumab y quimioterapia en tumores sólidos localmente avanzados o metastásicos
    A.4.1Sponsor's protocol code numberD8151C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 877 240 9479
    B.5.6E-mailinformation.center@astrazeneca.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 nameAZD0171
    D.3.2Product code AZD0171
    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 INNAZD0171
    D.3.9.2Current sponsor codeAZD0171
    D.3.9.3Other descriptive nameHumanised IgG1 monoclonal antibody against leukemia inhibitory factor
    D.3.9.4EV Substance CodeSUB232931
    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 IMFINZI™
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameMEDI4736
    D.3.9.4EV Substance CodeSUB175688
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Pancreatic ductal adenocarcinoma
    Adenocarcinoma ductal pancreático
    E.1.1.1Medical condition in easily understood language
    Pancreatic Cancer​
    Cáncer pancreático
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    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
    - To assess safety and tolerability of AZD0171 in combination with durvalumab and chemotherapy in participants with 1L mPDAC
    - To determine the preliminary OS of AZD0171 in combination with durvalumab and chemotherapy in participants with 1L mPDAC
    -Evaluar la seguridad y la tolerabilidad de AZD0171 en combinación con durvalumab y quimioterapia en el tratamiento de primera línea (1L) de participantes con PDAC metastásico (mPDAC)
    -Determinar de manera preliminar la OS con AZD0171 en combinación con durvalumab y quimioterapia en el tratamiento de 1L de participantes con mPDAC
    E.2.2Secondary objectives of the trial
    - To further characterise the preliminary (i) antitumour activity and (ii) survival activity of AZD0171 in combination with durvalumab and chemotherapy in participants with 1L mPDAC
    - To assess the preliminary antitumour activity of AZD0171 in combination with durvalumab and chemotherapy in participants with 1L mPDAC via circulating biomarkers
    - To assess immunogenicity of AZD0171 and/or durvalumab
    - To determine the PK profile of AZD0171, durvalumab and chemotherapy in participants with 1L mPDAC including LIF bound to AZD0171 (total LIF)
    - To assess changes in CD8+ T cell tumour infiltration associated with AZD0171 treatment in combination with durvalumab and chemotherapy in participants with 1L mPDAC
    For additional information please refer to section 3 of the protocol.
    -Caracterizar ampliamente de manera preliminar (i) la actividad antitumoral, y (ii) la actividad en cuanto a la supervivencia de AZD0171 en combinación con durvalumab y quimioterapia en el tratamiento de 1L de participantes con mPDAC
    -Evaluar de manera preliminar la actividad antitumoral de AZD0171 en combinación con durvalumab y quimioterapia en el tratamiento de 1L en participantes con mPDAC a través de los biomarcadores en la circulación
    -Evaluar la inmunogenia de AZD0171 y/o durvalumab
    -Determinar el perfil farmacocinético (pharmacokinetic, PK) de AZD0171, durvalumab y quimioterapia (gemcitabina y nab-paclitaxel) en el tratamiento de 1L de participantes con mPDAC, incluido el LIF unido a AZD0171 LIF Total)
    -Evaluar los cambios en las células T CD8+ infiltrantes del tumor como resultado del tratamiento de 1L con AZD0171 en combinación con durvalumab y quimioterapia en participantes con mPDAC
    Para los objetivos y criterios de valoración exploratorios, véase la Sección 3 del CSP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrolment
    • Must have a Gustave Roussy Immune Score of 0 or 1
    • Participants diagnosed with histologically confirmed pancreatic adenocarcinoma
    • Participants must have at least 1 measurable lesion to be called a target lesion according to RECIST v1.1
    • All participants must consent to providing sufficient archival specimen taken during metastatic stage or fresh tumour specimens for tumoural CD8+ T cell testing for enrolment
    • Presence of tumoural CD8+ T cells based on a predetermined benchmarked PDAC external sample
    • Normal organ and bone marrow function measured within 28 days prior to first dose of study intervention
    • Body weight ≥ 35 kg
    • Estado funcional del Eastern Cooperative Oncology Group de 0 1 en la selección/inclusión en el estudio
    • Gustave Roussy Immune Score de 0 o 1
    • Diagnóstico de adenocarcinoma pancreático confirmado histológicamente
    • Como mínimo 1 lesión medible, a calificar como lesión diana, según RECIST v1.1
    • Conformidad en aportar una muestra de archivo suficiente obtenida durante la fase metastásica o muestras frescas del tumor para examen de las células T CD8+ infiltrantes del tumor, para la inclusión en el estudio
    • Presencia de células T CD8+ infiltrantes del tumor, basada en una muestra externa de adenocarcinoma ductal pancreático como prueba patrón predeterminada
    • Funciones orgánica y de médula ósea normales, en su determinación en el plazo de los 28 días anteriores a la primera dosis del tratamiento del estudio
    • Peso corporal >/= 35 kg
    E.4Principal exclusion criteria
    • Symptomatic central nervous system metastasis or any history of leptomeningeal disease or cord compression
    • A participant with an already known sensitising mutation or tumour characteristic for pancreatic cancer for which there is a preferred local standard-of-care treatment
    • History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
    • Any unresolved toxicities ≥ Grade 2 per Common Terminology Criteria for Adverse Events v5.0 from prior therapy (excluding vitiligo, alopecia, controlled diabetes)
    • History of solid organ transplantation
    • History of active primary immunodeficiency
    • Ongoing or an active infection, including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. For Coronavirus disease 2019 (COVID-19) infections, a negative polymerase chain reaction test is required
    • Uncontrolled intercurrent illness
    • Participants with prior history of myocardial infarction, transient ischemic attack, coronary bypass, or stroke within the past 3 months prior to the first dose of study intervention
    • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms
    • Active or prior documented autoimmune or inflammatory disorders
    • History of another primary malignancy
    • Receipt of any conventional or investigational anticancer therapy prior to the scheduled first dose of study intervention
    • Prior receipt of any immune-mediated therapy
    • Use of immunosuppressive medication within 14 days prior to the first dose of study intervention
    • Receipt of live, attenuated vaccine within 28 days prior to the first dose of study intervention (Participants can receive non-live COVID-19 vaccines, at the discretion of the Investigator)
    • Metástasis sintomáticas en sistema nervioso central o cualquier antecedente de enfermedad leptomeníngea o de compresión de médula espinal
    • Conocimiento de mutación sensibilizante o característica tumoral del cáncer pancreático para el que existe un tratamiento de referencia localmente preferido
    • Antecedente de episodio tromboembólico en los 3 meses anteriores a la primera dosis programada del tratamiento del estudio
    • Cualquier efecto tóxico no resuelto de Grado >/= 2 según los Common Terminology Criteria for Adverse Events v5.0 del tratamiento previo (a excepción de vitíligo, alopecia y diabetes controlada)
    • Antecedente de trasplante de órgano sólido
    • Historia de inmunodeficiencia primaria activa
    • Infección actual o activa, incluidas tuberculosis, hepatitis B, hepatitis C o virus de la inmunodeficiencia humana. En cuanto a la infección por el coronavirus responsable de la COVID-19, se precisa un resultado negativo de la prueba de la reacción en cadena de la polimerasa
    • Enfermedad intercurrente no controlada
    • Antecedente de infarto de miocardio, ataque isquémico transitorio, cirugía de bypass coronario o accidente cerebrovascular en el plazo de los 3 meses anteriores a la primera dosis del tratamiento del estudio
    • Valor medio (de 3 electrocardiogramas) del intervalo QT corregido según la frecuencia cardíaca utilizando la fórmula de Fridericia (QTcF) >/=470 ms
    • Trastorno documentado activo o previo de carácter autoinmunitario o inflamatorio
    • Antecedente de otra neoplasia maligna primaria
    • Recepción de tratamiento antitumoral, ya sea convencional o experimental, antes de la primera dosis programada del tratamiento del estudio
    • Recepción previa de cualquier tratamiento de carácter inmunitario
    • Uso de medicación inmunosupresora en el plazo de los 14 días anteriores a la primera dosis del tratamiento del estudio
    • Recepción de una vacuna de gérmenes vivos atenuados en el plazo de los 28 días anteriores a la primera dosis del tratamiento del estudio (a criterio del investigador, los participantes puedan recibir vacunas de gérmenes no vivos frente al virus de la COVID-19)
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    - Incidence of AEs, imAEs and SAEs
    - Clinically meaningful changes from baseline in clinical laboratory parameters, vital signs, and ECG results
    Efficacy:
    - OS-12
    Seguridad:
    -Incidencia de acontecimientos adversos (adverse events, AEs), acontecimientos adversos de tipo inmune (immune mediated Aes, imAEs) y acontecimientos adversos graves (serious AEs, SAEs)
    -Cambios clínicamente importantes frente al basal en los resultados de los parámetros de laboratorio, constantes vitales y ECG
    Eficacia:
    -Supervivencia global (overall survival) a los 12 meses (OS-12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline
    Desde la basal
    E.5.2Secondary end point(s)
    Efficacy:
    - According to RECIST v1.1:
    - (i) ORR, DCR, DoR
    - (ii) PFS, PFS-4, OS
    - Serum CA19-9

    Immunogenicity :
    - Incidence of detectable ADAs against AZD0171 and/or durvalumab in serum

    Pharmacokinetic :
    - Summary of PK parameters for AZD0171, total LIF, durvalumab and chemotherapies and/or their metabolites (ie, Cmax, AUC, CL, and terminal elimination t1/2)

    Pharmacodynamic :
    - Assessment of CD8+ T cell tumour infiltration in tumour samples at baseline and on treatment
    Eficacia:
    -Según RECIST v1.1:
    -(i) Tasa de respuesta objetiva (objective response rate, ORR), tasa de control de la enfermedad (disease control rate, DCR) y duración de la respuesta (duration of response, DoR)
    (ii) Mediana de la supervivencia sin progresión (progression free survival, PFS), PFS a los 4 meses (PFS-4) y mediana de la supervivencia global (overall survival, OS)
    -Niveles séricos de CA19-9

    Inmunogenicidad:
    -Incidencia de anticuerpos antifármaco (anti-drug antibodies, ADAs) detectables frente a AZD0171 y/o durvalumab en suero

    Farmacocinética:
    -Resumen de los parámetros PK de AZD0171, LIF total, durvalumab y chemotherapies y/o sus metabolitos (esto es, Cmax, AUC, CL, y semivida de eliminación terminal [t1/2])

    Farmacodinámica:
    -Evaluación de las células T CD8+ infiltrantes del tumor en muestras de tumor obtenidas en el basal y durante el tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and on treatment
    en la basal y en tratamiento
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Canada
    United States
    France
    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
    LVLS
    Último paciente, última visita
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 115
    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)
    Patients after d/c of study therapy will be further treated per Investigator discretion (options are 2nd line SoC anticancer therapy or eventually within another clinical study, or BSC)
    Tras la suspensión del tratamiento del estudio, el tratamiento posterior de los pacientes quedará a criterio del investigador (las posibles opciones son un tratamiento antitumoral de referencia de segunda línea, la entrada en otro estudio clínico o el mejor tratamiento de apoyo)
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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