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    Summary
    EudraCT Number:2021-003569-36
    Sponsor's Protocol Code Number:D9571C00001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-003569-36
    A.3Full title of the trial
    A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma
    Etude multicentrique, de phase I/II, en ouvert, évaluant la sécurité, la tolérance, la pharmacocinétique et l'efficacité préliminaire de l'AZD7789, un anticorps bispécifique anti-PD-1 et anti-TIM3, chez des patients présentant un lymphome de Hodgkin classique récidivant ou réfractaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label, Multi-center Study to Assess the Safety and Preliminary Efficacy of AZD7789 in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
    Etude multicentrique en ouvert évaluant la sécurité et l'efficacité préliminaire de l'AZD7789 chez des patients présentant un lymphome de Hodgkin classique récidivant ou réfractaire (LHc)
    A.4.1Sponsor's protocol code numberD9571C00001
    A.5.4Other Identifiers
    Name:INDNumber:157025
    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 AB,
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike
    B.5.3.2Town/ cityWilmington, DE
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    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 nameAZD7789
    D.3.4Pharmaceutical form Powder 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameAZD7789
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Relapse/Refractory Classical Hodgkin Lymphoma
    Lymphome de hodgkin classique récidivant ou réfractaire
    E.1.1.1Medical condition in easily understood language
    Cancer of the lymphatic system
    Cancer du système lymphatique
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080208
    E.1.2Term Classical Hodgkin lymphoma
    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
    Part A Dose Escalation:
    • To assess the safety and tolerability of AZD7789 in participants with r/r cHL
    • To establish the maximum tolerated dose, or optimal biological dose, and recommended Phase 2 dose

    Part B Dose Expansion (all):
    • To assess the safety and tolerability of AZD7789 in participants with r/r cHL

    Part B Dose Expansion (B1):
    • To assess the preliminary antitumor activity of AZD7789 in participants with r/r cHL (anti-PD-1/PD-L1 exposed)

    Part B Dose Expansion (B2):
    • To assess the preliminary antitumor activity of AZD7789 in patients with r/r cHL (anti PD-1/PD-L1 naïve)
    Partie A Escalade de dose :
    • Évaluer la sécurité et la tolérance de l’AZD7789 chez des participants atteints de LHc r/r
    • Établir la dose maximale tolérée ou la dose biologique optimale et la dose recommandée pour la phase 2

    Partie B Expansion de dose (tous les participants) :
    • Evaluer la sécurité et la tolérance de l’AZD7789 chez des participants atteints de LHc r/r

    Partie B Expansion de dose (B1) :
    • Évaluer l’activité antitumorale préliminaire de l’AZD7789 chez des participants atteints de LHc r/r (exposés à un traitement antérieur par anti-PD-1/PD-L1)

    Partie B Expansion de dose (B2):
    • Évaluer l’activité antitumorale préliminaire de l’AZD7789 chez des participants atteints de LHc r/r (naïfs de tout traitement par anti-PD-1/PD-L1)
    E.2.2Secondary objectives of the trial
    Part A Dose Escalation:
    • To assess the preliminary antitumor activity of AZD7789 in participants with r/r cHL

    Part B Dose Expansion:
    • To further assess the preliminary antitumor activity of AZD7789 in participants with r/r cHL

    Part A Dose Escalation and Part B Dose Expansion:
    • To assess the PK of AZD7789 in participants with r/r cHL
    • To assess the immunogenicity of AZD7789 in participants with r/r cHL
    Partie A Escalade de dose :
    • Évaluer l’activité antitumorale préliminaire de l’AZD7789 chez des participants atteints de LHc r/r

    Partie B Expansion de dose :
    • Évaluer davantage l’activité antitumorale préliminaire de l’AZD7789 chez des participants atteints de LHc r/r.
    DdR et DdRC.

    Partie A Escalade de dose et Partie B Expansion de dose
    • Évaluer la PK de l’AZD7789 chez des participants atteints de LHc r/r.
    • Évaluer l’immunogénicité de l’AZD7789 chez des participants atteints de LHc r/r.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Genomics Initiative Sample
    A saliva sample for DNA isolation will be collected from patients who have consented to participate in the genetic analysis component of the study. Participation is optional. Patients who do not wish to participate in the genetic research may still participate in the study.
    Recherche optionnelle Initiative génomique

    Un échantillon de salive pour isolation d'ADN sera prélevé chez les patients ayant consenti à participer à l'analyse génétique, volet de cette étude. La participation est optionnelle. Les patients ne souhaitant pas participer à la recheche génétique peuvent toujours participer à l'étude.
    E.3Principal inclusion criteria
    1. Must be ≥ 18 years of age at the time of obtaining informed consent
    2. Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
    3. Must have at least one PET-avid measurable lesion according to Modified Lugano Criteria
    4. Confirmed histological diagnosis of active relapse/refractory cHL
    5. Must have failed at least 2 prior lines of systemic therapy. In part A dose escalation and part B dose expansion cohort B1, the prior lines of therapy must include at least 3 cycles of an anti-PD-1/PD-L1 therapy. In part B dose expansion cohort B2, prior anti-PD-1/PD-L1 therapy is excluded. For all participants, no previous treatment with anti-TIM-3 is allowed. Previous anti-CTLA-4 treatment is acceptable with at least 2 months washout period prior to study entry
    6. Adequate organ and bone marrow function measured within 7 days prior to first dose
    7. Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
    1. Âge ≥ 18 ans au moment de la signature du formulaire de consentement éclairé
    2. Bilan de performances ECOG (Eastern Cooperative Oncology Group) de 0 ou 1 à la sélection
    3. Présence d’au moins une lésion mesurable avide en TEP, selon les critères de Lugano modifiés.
    4. Diagnostic de LHc récidivant ou réfractaire confirmé histologiquement
    5. Échec d’au moins 2 lignes antérieures de traitement systémique. Dans la partie A, escalation de dose et la partie B, expansion de dose, cohorte B1, les lignes antérieures de traitement doivent inclure au moins 3 cycles de traitement à base d’anti-PD-1/PD-L1. Dans la partie B, expansion de dose, cohorte B2, exclusion de traitement antérieur à base d’anti-PD-1/PD-L1. Pour tous les participants, aucun traitement antérieur par anti-TIM-3 n'est autorisé. Un traitement antérieur par anti-CTLA-4 est autorisé mais toutefois, uniquement jusqu’à 2 mois avant l’entrée dans l’étude
    6. Fonction appropriée des organes et de la moelle osseuse, mesurée dans les 7 jours précédant la première dose
    7. Les femmes en âge de procréer participant à l’étude doit éviter de devenir enceinte et les hommes participant à l’étude devront s'abstenir d’engendrer un enfant en utilisant desmoyens de contraception hautement efficace
    E.4Principal exclusion criteria
    1. Unresolved toxicities of ≥ Grade 2 from prior therapy
    2. Any prior ≥ Grade 3 imAE while receiving immunotherapy
    3. Participants with CNS involvement or leptomeningeal disease.
    4. History of organ transplantation (e.g., stem cell or solid organ transplant).
    5. Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose of study intervention.
    6. Infectious disease exclusions: Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
    7. History of arrhythmia which is requires treatment; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
    8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable angina pectoris, history of myocardial infarction within the past 6 months, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease
    9. Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.. Some exceptions have been specified in the protocol
    10. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
    11. Other invasive malignancy within 2 years prior to screening
    12. Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
    13. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
    14. Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions is acceptable.
    1. Toxicités non résolues ≥ Grade 2 (NCI CTCAE v5.0) dues au traitement antérieur
    2. Tout antécédent d’EIim ≥ Grade 3 pendant l’immunothérapie
    3. Atteinte du SNC ou leptoméningée.
    4. Antécédents de greffe d’organe (greffe de cellules souches ou d'organe solide)
    5. Tout événement thrombo-embolique veineux ou artériel dans les ≤ 6 mois précédant la première dose d’intervention à l’étude.
    6. Critères de non-inclusion relatifs aux infections : infection active, y compris tuberculose, VIH, hépatite A, hépatite B chronique ou active, hépatite C chronique ou active, infection COVID-19 active
    7. Antécédents d’arythmie nécessitant un traitement ; fibrillation auriculaire symptomatique ou non contrôlée malgré un traitement, ou tachycardie ventriculaire prolongée asymptomatique
    8. Présence d’une pathologie intercurrente non contrôlée, notamment : infection en cours ou active, cardiomyopathie de n’importe quelle étiologie, insuffisance cardiaque congestive symptomatique, hypertension artérielle non contrôlée, diabète non contrôlé, angor instable, antécédents d’infarctus du myocarde dans les ≤ 6 mois précédents, pathologies gastro-intestinales chroniques graves associées à une diarrhée, pathologie cutanée non infectieuse active
    9. Présence ou antécédents de pathologies auto-immunes ou inflammatoires documentées, y compris maladies intestinales inflammatoires (par exemple, colite ou maladie de Crohn), diverticulites (à l’exception de la diverticulose), lupus érythémateux disséminé, syndrome de sarcoïdose ou syndrome de Wegener (granulomatose avec polyangiite), maladie de Graves, polyarthrite rhumatoïde, hypophysite, uvéite, etc. Certaines exceptions sont précisées dans le protocole
    10. Antécédents médicaux de pneumopathie interstitielle (PNI), PNI iatrogène, pneumopathie inflammatoire radique ayant nécessité une corticothérapie ou tout signe de PNI cliniquement active
    11. Autre cancer invasif dans les 2 ans avant la sélection
    12. Syndrome du QT long congénital ou antécédents d’allongement de l’intervalle QT associé à d’autres médicaments ne pouvant pas être modifiés ou arrêtés d’après l’évaluation du cardiologue
    13. Utilisation en cours ou antérieure d’un médicament immunosuppresseur dans les 14 jours précédant la première dose de traitement à l’étude
    14. Tout traitement concomitant (chimiothérapie, radiothérapie, agent expérimental, agent biologique ou hormonothérapie) pour le traitement du cancer. L’utilisation concomitante d’une hormonothérapie pour des pathologies non liées au cancer est acceptable
    E.5 End points
    E.5.1Primary end point(s)
    Part A Dose Escalation:
    • Incidence of AEs, imAEs, and SAEs
    • Incidence of AEs leading to discontinuation of AZD7789
    • Changes from baseline and clinically significant alterations in vital signs, laboratory parameters, and ECG results
    • Incidence of dose-limiting toxicities

    Part B Dose Expansion (all):
    • Incidence of AEs, imAEs, and SAEs
    • Incidence of AEs leading to discontinuation of AZD7789
    • Changes from baseline and clinically significant alterations in vital signs, laboratory parameters, and ECG results

    Part B Dose Expansion (B1):
    • Objective Response Rate (defined as the proportion of patients with complete remission or partial remission)

    Part B Dose Expansion (B2):
    • Complete Response Rate (defined as the proportion of patients with complete remission)
    Partie A Escalade de dose :
    • Incidence des EI, EIim et EIG
    • Incidence des EI conduisant à l’arrêt de l’AZD7789
    • Modifications par rapport aux valeurs initiales et altérations cliniquement significatives des signes vitaux, des résultats des analyses biologiques et des ECG
    • Incidence des toxicités limitant la dose

    Partie B Expansion de dose (tous les participants) :
    • Incidence des EI, EIim et EIG
    • Incidence des EI conduisant à l’arrêt de l’AZD7789
    • Modifications par rapport aux valeurs initiales et altérations cliniquement significatives des signes vitaux, des résultats des analyses biologiques et des ECG

    Partie B Expansion de dose (B1) :
    • Taux de réponse objective (défini comme la proportion de patients ayant une rémission complète ou une rémission partielle)

    Partie B Expansion de dose (B2) :
    • Taux de réponse complète (défini comme la proportion de patients ayant une rémission complète)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study design at various timepoints.
    Tout au long de l'étude
    E.5.2Secondary end point(s)
    Part A Dose Escalation:
    • Complete Response Rate, Objective Response Rate, DoR, and DoCR
    • PFS including landmarks at 12 and 24 months
    • OS including landmarks at 12 and 24 months

    Part B Dose Expansion:
    • DoR and DoCR
    • PFS b including landmarks at 12 and 24 months
    • OS including landmarks at 12 and 24 months

    Part A Dose Escalation and Part B Dose Expansion
    • PK parameters including the maximum observed concentration, area under the concentration-time curve, clearance and terminal elimination half life
    • Incidence of anti-drug antibodies against AZD7789 in serum.
    Partie A Escalade de dose :
    • Taux de réponse complète, taux de réponse objective, DdR et DdRC
    • SSP y compris points temporels repères à 12 et 24 mois
    • SG y compris points temporels repères à 12 et 24 mois

    Partie B Expansion de dose :
    • DdR et DdRC
    • SSP y compris points temporels repères à 12 et 24 mois
    • SG y compris points temporels repères à 12 et 24 mois

    Partie A Escalade de dose et Partie B Expansion de dose :
    • Paramètres PK incluant la concentration observée maximale, l’aire sous la courbe concentration-temps, la clairance et la demi-vie d’élimination terminale
    • Incidence des anticorps anti-médicament dirigés contre l’AZD7789 dans le sérum
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study design at various timpoints.
    Tout au long de l'étude
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Phase I/II open label multi center, dose escalation and dose expansion study.
    Etude multicentrique, de phase I/II en ouvert, escalade de dose et expansion de dose
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II open label multi center, dose escalation and dose expansion study.
    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.8.4.1Number 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 EEA15
    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
    Australia
    Canada
    Denmark
    Germany
    Italy
    Portugal
    Spain
    United Kingdom
    United States
    France
    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 end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure for the last participant in the study globally.
    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 months9
    E.8.9.1In the Member State concerned days20
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 180
    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.
    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 Decision2022-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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