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    Summary
    EudraCT Number:2020-004782-39
    Sponsor's Protocol Code Number:DS8201-A-U207
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004782-39
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Subjects with HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trastuzumab deruxtecan for subjects with HER2-overexpressing advanced or metastatic CRC
    A.3.2Name or abbreviated title of the trial where available
    DESTINY-CRC02
    A.4.1Sponsor's protocol code numberDS8201-A-U207
    A.5.4Other Identifiers
    Name:IND numberNumber:136179
    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 SponsorDaiichi Sankyo Inc.
    B.1.3.4CountryUnited States
    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 supportDaiichi Sankyo Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Inc.
    B.5.2Functional name of contact pointDavid Rusnak
    B.5.3 Address:
    B.5.3.1Street Address211 Mount Airy Road
    B.5.3.2Town/ cityBasking Ridge
    B.5.3.3Post codeNJ 07920
    B.5.3.4CountryUnited States
    B.5.4Telephone number1908992 7876
    B.5.6E-maildrusnak@dsi.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 T-DXd, 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 1826843-81-5
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.3Other descriptive nameAnti-HER2 antibody-drug conjugate
    D.3.9.4EV Substance CodeSUB188357
    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 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
    HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer
    E.1.1.1Medical condition in easily understood language
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 the efficacy of T-DXd, as measured by the confirmed ORR by BICR in HER2-overexpressing (defined as IHC 3+ or IHC 2+/ISH+) mCRC subjects treated at the 5.4 mg/kg and 6.4 mg/kg doses
    E.2.2Secondary objectives of the trial
    • To evaluate the clinical efficacy of T-DXd by confirmed ORR by Investigator assessment;
    • To evaluate the clinical efficacy of T-DXd by DoR;
    • To further evaluate the clinical efficacy of T-DXd by DCR, CBR, PFS and OS;
    • To further evaluate the safety and tolerability of T-DXd;
    • To evaluate HEOR endpoints including patient-reported HRQoL, symptoms, and physical functioning;
    • To evaluate healthcare resource utilization for both treatment arms;
    • To evaluate PK of T-DXd;
    • To evaluate immunogenicity of T-DXd.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign and date the Tissue Pre-Screening and Main ICFs, prior to the start of any respective study-specific qualification procedures.
    2. Adults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥ 18 years in other countries, at the time the ICFs are signed. (Please follow local regulatory requirements if the legal age of consent for study participation is >18 years).
    3. Pathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Subject must have BRAF wild-type cancer and RAS status identified in primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA), ISO15189, or equivalent-certified laboratory.
    4. The following therapies should be included in prior lines of therapy:
    a. Fluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated
    b. Anti-EGFR treatment, if RAS wild-type and if clinically indicated
    c. Anti-VEGF treatment, if clinically indicated
    d. Anti-PD-(L)-1 therapy, if tumor is MSI-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated
    5. Is willing and able to provide an adequate tumor sample for tissue pre-screening to confirm HER2 status by central laboratory (most recent tumor tissue preferred).
    6. Confirmed HER2-overexpressing status assessed by central laboratory and defined as IHC 3+ or IHC 2+/ISH+.
    7. Presence of at least one measurable lesion assessed by the Investigator per RECIST version 1.1. Lesions situated in a previously-irradiated area are considered measurable if progression has been demonstrated in such lesions after the end of radiotherapy.
    8. ECOG PS of 0 or 1.
    9. Has LVEF ≥50% within 28 days before randomization/registration.
    10. Has adequate organ function within 14 days before randomization/registration as defined in the protocol.
    11. Has adequate treatment washout period before randomization/registration as defined in the protocol.
    12. If the subject is a woman of childbearing potential, she must have a negative urine pregnancy test within 72 hours before randomization/registration; a positive urine pregnancy test result must immediately be confirmed using a serum test. The subject must also be willing to use highly effective birth control, as detailed in Section 10.3.4, upon randomization/registration, during the Treatment Period, and for 7 months, following the last dose of study drug. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral
    salpingectomy, or bilateral oophorectomy).
    a. Non-childbearing potential is defined as premenopausal female subjects with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone [FSH] >40 mIU/mL and estradiol <40 pg/mL [<147 pmol/L] is confirmatory). Female subjects on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to randomization/registration. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method.
    13. If male, the subject must be surgically sterile or willing to use highly effective birth control (Section 10.3.4) upon randomization/registration, during the Treatment Period, and for 4 months following the last dose of study drug.
    14. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to randomization/registration in this study.
    15. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study Treatment Period, and for at least 7 months after the final study drug administration.
    16. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
    17. Life expectancy is ≥3 months.
    E.4Principal exclusion criteria
    1. Medical history of myocardial infarction (MI) within 6 months before randomization/registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at Screening (as defined by the manufacturer), and without any MI-related symptoms, should have a cardiologic consultation before randomization/registration to rule out MI.
    2. Has a corrected QT interval (QTcF) prolongation to >470 msec (female subjects) or >450 msec (male subjects) based on the average of the Screening triplicate 12-lead ECGs.
    3. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
    4. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the randomization/registration, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.).
    5. Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren syndrome, sarcoidosis, etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of Screening. Full details of the disorder should be recorded in the electronic case report form (eCRF) for subjects who are included in the study.
    6. Prior pneumonectomy.
    7. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and randomization/registration.
    8. Subjects with leptomeningeal carcinomatosis.
    9. Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
    10. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
    11. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
    12. Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
    13. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions that may in the opinion of the Investigator, interfere with the subject’s participation in the clinical study or evaluation of the clinical study results.
    14. Has known human immunodeficiency virus (HIV) infection. Unless required by local regulations or institutional review board (IRB)/ethics committee (EC), an HIV antigen/antibody test is not required prior to randomization/enrollment.
    15. Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days before study randomization/registration. Subjects with past or resolved hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen (HBsAg) negative (-) and antibody to hepatitis B core antigen (anti-HBc) positive (+). Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    16. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, Grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator and approval of the Sponsor.
    17. Previous treatment with a DXd-containing ADC.
    18. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection. Note: Subjects with localized fungal infections of skin or nails are eligible.
    19. Female subject who is pregnant, breastfeeding, or intends to become pregnant during the study.
    20. Psychological, social, familial, or geographical factors that would prevent regular follow-up.
    21. Otherwise considered inappropriate for the study by the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed objective response rate (ORR), defined as the proportion of subjects with CR or PR, assessed by BICR based on RECIST version 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the first 80 subjects are randomized for the IA and 6 months after the last subject is registered for the primary analysis
    E.5.2Secondary end point(s)
    - Confirmed ORR;
    - Duration of response (DoR);
    - Disease control rate (DCR);
    - Clinical benefit rate (CBR);
    - Progression-free survival (PFS);
    - Overall survival (OS);
    - TEAEs (including SAEs and AESIs);
    - PROs;
    - PK profile;
    - Incidence of ADA and NAb
    E.5.2.1Timepoint(s) of evaluation of this end point
    Confirmed ORR, DoR, TEAEs: 12 weeks after the first 80 subjects are randomized for the IA and 6 months after the last subject is registered for the primary analysis
    DCR, PFS, DCR, CBR, OS: 12 weeks after the first 80 subjects are randomized for the IA (DCR, PFS) and 6 months after the last subject is registered for the primary analysis (DCR, CBR, PFS, OS)
    PROs, PK Profile, Incidence of ADA and NAb: 6 months after the last subject is registered or later
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Biomarker Analysis, Immunogenicity, Health economics and outcomes research (HEOR), Quality of Life (QoL), Healthcare resource utilization etc.
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Different dose of the same IMP
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Japan
    Korea, Republic of
    Taiwan
    United States
    Belgium
    France
    Italy
    Spain
    United Kingdom
    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
    Overall end of study will occur when the last subject last visit has occurred or the study is discontinued by the Sponsor for other reasons (administrative, program-level, or class-related).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 120
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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