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    Summary
    EudraCT Number:2020-002368-30
    Sponsor's Protocol Code Number:D967MC00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002368-30
    A.3Full title of the trial
    A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring ER2 Activating Mutations Regardless of Tumor Histology
    Studio di fase II, multicentrico, in aperto, per valutare l’efficacia e la sicurezza di Trastuzumab Deruxtecan (T-DXd) per il trattamento di tumori solidi non resecabili e/o metastatici portatori di mutazioni attivanti HER2, indipendentemente dall’istologia del tumore.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate anti-tumor activity and safety of trastuzumab deruxtecan in patients with solid tumors carrying specific HER2 mutations.
    Studio per valutare l’attività antitumorale e la sicurezza di Trastuzumab Deruxtecan in pazienti con tumori solidi portatori di specifiche mutazioni HER2
    A.3.2Name or abbreviated title of the trial where available
    DESTINY-PanTumor01
    DESTINY-PanTumor01
    A.4.1Sponsor's protocol code numberD967MC00001
    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 AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.4Telephone number0000000
    B.5.5Fax number000000
    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 nameTrastuzumab deruxtecan
    D.3.2Product code [DS-8201a]
    D.3.4Pharmaceutical form Powder for 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 INNTrastuzumab Deruxtecan
    D.3.9.1CAS number 1599440-13-7
    D.3.9.2Current sponsor codeDS-8201a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology.
    Trattamento di tumori solidi non resecabili e / o metastatici portatori di specifiche mutazioni attivanti HER2 indipendentemente dall'istologia del tumore
    E.1.1.1Medical condition in easily understood language
    Patients with advanced solid tumors carrying specific HER2 mutations.
    Pazienti con tumori solidi avanzati portatori di mutazioni HER2 specifiche
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of T-DXd in patients with metastatic or unresectable tumors harboring specific HER2 activating mutations across tumor types.
    Valutare l'efficacia di T-DXd in pazienti con tumori metastatici o non resecabili portatori di specifiche mutazioni attivanti HER2 tra i tipi di tumore
    E.2.2Secondary objectives of the trial
    - To further assess the efficacy of T-DXd in patients with metastatic or unresectable tumors harboring pre-specified HER2 activating mutations across tumor types.
    - To assess the safety and tolerability of T-DXd.
    - To assess the PK of T-DXd, total anti-HER2 antibody and MAAA-1181a in serum.
    - To investigate the immunogenicity of T-DXd.
    - Valutare ulteriormente l'efficacia di T-DXd in pazienti con tumori metastatici o non resecabili portatori di mutazioni attivanti HER2 pre-specificate tra i tipi di tumore.
    - Valutare la sicurezza e la tollerabilità di T-DXd.
    - Per valutare la PK di T-DXd, anticorpi totali anti-HER2 e MAAA-1181a nel siero.
    - Studiare l'immunogenicità di T-DXd.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults =18 years old. Other age restrictions may apply as per local regulations.
    • Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
    • Prior HER2 targeted therapy is permitted.
    • All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
    • LVEF =50%
    • ECOG 0-1
    • Adulti = 18 anni. Potrebbero essere applicate altre limitazioni di età in base alle normative locali.
    • Tumori solidi non resecabili e / o metastatici ,con mutazioni HER2 pre-specificate determinate localmente mediante NGS, che sono progrediti dopo un trattamento precedente o che non hanno opzioni di trattamento alternative soddisfacenti.
    • È consentita una precedente terapia “HER2-targeted”.
    • Tutti i pazienti devono fornire un campione di tumore FFPE per il test di HER2 retrospettivo centralizzato.
    • LVEF =50%
    • ECOG 0-1
    E.4Principal exclusion criteria
    • HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
    • HER2 mutant NSCLC.
    • History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
    • Lung-specific intercurrent clinically significant severe illnesses.
    • History of active primary immunodeficiency, known HIV, active HBV or HCV infection
    • Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
    • Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
    • Has spinal cord compression or clinically active central nervous system metastases.
    • Adenocarcinoma mammario, gastrico o della giunzione gastroesofagea con sovraespressione di HER2 (IHC3 + o IHC2 + / ISH +).
    • NSCLC con mutazione HER2.
    • Anamnesi di polmonite / ILD non infettiva, ILD in corso o dove non è possibile escludere una sospetta ILD mediante imaging allo screening
    • Malattie gravi intercorrenti clinicamente significative specifiche del polmone.
    • Storia di immunodeficienza primaria attiva, infezione nota da HIV, infezione attiva da HBV o HCV
    • Infezione incontrollata che richiede antibiotici per via endovenosa (EV), antivirali o antimicotici
    • Versamento pleurico, ascite o versamento pericardico che richiede drenaggio, shunt peritoneale o terapia di reinfusione di ascite concentrata e priva di cellule (CART).
    • Presenta compressione del midollo spinale o metastasi del sistema nervoso centrale clinicamente attive.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed objective response rate by RECIST v1.1 based on independent central review (ICR).
    Tasso di risposta obiettiva confermato da RECIST v1.1 basato sulla revisione centrale indipendente (ICR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    An average of approximately 12 months.
    Una media di circa 12 mesi
    E.5.2Secondary end point(s)
    1) Duration of response (DoR) based on ICR assessment.
    2) Disease control rate (DCR) based on ICR assessment.
    3) Progression free survival (PFS) based on ICR assessment.
    4) Confirmed Objective Response Rate (ORR) based on investigator assessment.
    5) Overall survival (OS).
    6) Occurrence of adverse events (AEs) and serious adverse events (SAEs).
    7) Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181.
    8) The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd.
    1) Durata della risposta (DoR) basata sulla valutazione ICR.
    2) Tasso di controllo della malattia (DCR) basato sulla valutazione ICR.
    3) Sopravvivenza libera da progressione (PFS) basata sulla valutazione ICR.
    4) Tasso di risposta obiettiva (ORR) confermato in base alla valutazione dello sperimentatore.
    5) Sopravvivenza globale (OS).
    6) Presenza di eventi avversi (AE) ed eventi avversi gravi (SAE).
    7) Farmacocinetica (PK) valutata in base alla concentrazione sierica di T-DXd, anticorpi totali anti-HER2 e MAAA-1181.
    8) L'immunogenicità di T-DXd valutata dalla presenza di ADA per T-DXd.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) An average of approximately 12 months.
    2) An average of approximately 12 months.
    3) An average of approximately 12 months.
    4) An average of approximately 12 months.
    5) An average of approximately 20 months.
    6) An average of approximately 14 months.
    7) An average of approximately 14 months.
    8) An average of approximately 14 months.
    1) Una media di circa 12 mesi.
    2) Una media di circa 12 mesi.
    3) Una media di circa 12 mesi.
    4) Una media di circa 12 mesi.
    5) Una media di circa 20 mesi.
    6) Una media di circa 14 mesi.
    7) Una media di circa 14 mesi.
    8) Una media di circa 14 mesi.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    singolo gruppo
    Single group
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    NA
    NA
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    Korea, Republic of
    United States
    Belgium
    France
    Italy
    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 end of the study is defined as the time of the final DCO (data cutoff) for the final analysis. Final analysis is planned to be performed when the last patient has had the opportunity for approximately 32 weeks of follow-up after treatment assignment.
    La fine dello studio è definita come il tempo del DCO finale (data cutoff) per l'analisi finale. L'analisi finale è pianificata per essere eseguita quando l'ultimo paziente ha avuto l'opportunità di circa 32 settimane di follow-up dopo l'assegnazione del trattamento.
    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 months0
    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
    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: 50
    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 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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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)
    No intervention is planned after the end of the study. However, provisions will be in place for patients still ongoing at the end of the study to continue to receive IP if, in the opinion of the Investigator, they are continuing to receive benefit from treatment.
    Nessun intervento è previsto dopo la fine dello studio. Tuttavia, saranno in vigore disposizioni per i pazienti ancora in corso alla fine del studio per continuare a ricevere l’IMP se, a parere dello sperimentatore, continuano a ricevere benefici dal trattamento.
    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 Decision2021-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
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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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