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    EudraCT Number:2019-002888-10
    Sponsor's Protocol Code Number:SYD985.003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-21
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-002888-10
    A.3Full title of the trial
    A single-arm phase II trial to evaluate the safety and efficacy of the antibody-drug conjugate SYD985 in patients with HER2-expressing recurrent, advanced or metastatic endometrial carcinoma who previously progressed on or after first line platinum-based chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate the safety and efficacy of SYD985 in patients with advanced or metastatic endometrial carcinoma who previously received platinum-based chemotherapy
    A.4.1Sponsor's protocol code numberSYD985.003
    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 SponsorByondis BV
    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 supportByondis BV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationByondis BV
    B.5.2Functional name of contact pointClinical Project Leader
    B.5.3 Address:
    B.5.3.1Street AddressMicroweg 22
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6545 CM
    B.5.4Telephone number+31243727966
    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.3.2Product code SYD985
    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 duocarmazine
    D.3.9.1CAS number 1642152-40-6
    D.3.9.2Current sponsor codeSYD985
    D.3.9.3Other descriptive nametrastuzumab valine-citrulline-seco-duocarmycin-hydroxybenzamide-azaindole (trastuzumab vc-seco-DUBA)
    D.3.9.4EV Substance CodeSUB188356
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typean antibody-drug conjugate (ADC)
    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
    Recurrent, Advanced or Metastatic Endometrial Carcinoma
    E.1.1.1Medical condition in easily understood language
    Patients with HER2-expressing recurrent, advanced or metastatic endometrial carcinoma who previously progressed on or after first line platinum-based chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014743
    E.1.2Term Endometrial carcinoma
    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 evaluate the objective tumour response rate (ORR) of SYD985.
    E.2.2Secondary objectives of the trial
    To evaluate for SYD985:
    • Progression-free survival (PFS);
    • Overall survival (OS);
    • Safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients, age ≥18 years at the time of signing main informed consent;
    2. Patients with histologically confirmed recurrent, advanced or metastatic endometrial carcinoma (including endometrioid, mucinous, serous, squamous, clear-cell, undifferentiated or mixed carcinoma or carcinosarcoma);
    3. Eligible patients should have progressed on or after one prior systemic platinum-based chemotherapy regimen for endometrial cancer. Patients who have had two or more lines of chemotherapy are not eligible:
    - Patients may have received up to one additional line of chemotherapy if given in the neoadjuvant or adjuvant setting provided that such treatment was completed more than 6 months prior to the current tumour recurrence or progression;
    - No more than one line of non-cytotoxic systemic cancer therapy (such as immunotherapy, trastuzumab or protein kinase inhibitors) is allowed.
    Note: there is no restriction regarding to the lines of prior hormonal therapy.
    4. HER2 tumour expression defined as a 1+, 2+ or 3+ score on IHC or positive by ISH as determined by the central laboratory on most recent available/obtained tumour material;
    5. At least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumours (RECIST version 1.1);
    6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
    7. Adequate organ function, evidenced by the following (local) laboratory results:
    – Absolute neutrophil count ≥ 1.5 x 109/L;
    – Platelet count ≥ 100 x 109/L;
    – Hemoglobin ≥ 9.0 g/dL or 5.6 mmol/L;
    – Total bilirubin ≤ 1.5 x the upper limit of normal (ULN);
    – Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases);
    – Serum creatinine ≤ 1.5 x ULN;
    8. For women of childbearing potential highly effective contraception must be used during the study and up to at least 6 months after last study treatment. This is not required in case the patient or sole partner is surgically sterilized or in case the patient truly abstains from sexual activity.
    E.4Principal exclusion criteria
    1. Having been treated with:
    a. Any HER2-targeting antibody-drug conjugate (ADC) therapy;
    b. Anthracycline treatment within 8 weeks prior to start IMP treatment;
    c. Other anticancer therapy including chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to start IMP treatment or 5 times the half-life of the therapy, whichever is shorter;
    d. Radiotherapy within 4 weeks prior to start IMP treatment, or within 1 week prior to start IMP treatment for palliative care (as long as the lungs were not exposed);
    e. Hormone therapy within 1 week prior to start IMP treatment;
    The patient must have sufficiently recovered from any treatment-related toxicities to CTCAE Grade ≤ 1 (except for toxicities not considered a safety risk for the patient at the investigator’s discretion);
    2. History of infusion-related reactions and/or hypersensitivity to trastuzumab or excipients of the study drug which led to permanent discontinuation of the treatment;
    3. History or presence of keratitis;
    4. Severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) at screening;
    5. Left ventricular ejection fraction (LVEF) < 50% as assessed by either echocardiography or multigated acquisition (MUGA) scan at screening, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab leading to permanent discontinuation of treatment;
    6. History (within 6 months prior to start IMP treatment) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication;
    7. Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to start IMP treatment;
    8. History or presence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan;
    9. Known active Hepatitis B, C or E infection;
    10. Major surgery within 4 weeks prior to start IMP treatment;
    11. Pregnancy or lactation;
    12. Other condition, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is ORR based on investigator assessed tumour assessment according to RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumour assessments should include an evaluation of all known and/or suspected sites of disease, whenever possible. Patients should have lesions selected that can be evaluated at every tumour assessment. Patients with non-measurable disease whose non-target lesions are not assessed at a follow-up visit will be considered unevaluable at that visit unless PD is assessed.
    Tumour evaluation: Screening, Every 6 weeks for first 24 wks, thereafter every 12 wks, Treatment discontinuation Visit, Observation Phase Visits
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • PFS;
    • OS;
    • Safety.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Survival information gathered during: Observation phase and Survival Follow up.
    The Observation Phase is for any patient that discontinued study treatment for reasons other than PD (e.g. toxicity). Patients stay in the Observation Phase until the time of PD or the start of a new anticancer treatment.
    Every 3 months (±14 days) following the last visit/contact (i.e. 30-day follow up visit or final observation phase visit) patient should be contacted for survival until death, lost to follow-up or consent withdrawal, whichever comes first. During this follow-up only survival information and initiation of new anticancer medication should be documented.
    Ongoing safety evaluation till Follow-up Visit.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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. 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 concerned3
    E.8.5The trial involves multiple Member States No
    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
    Korea, Democratic People's Republic of
    Russian Federation
    United States
    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 overall study ends when the last patient completed the last study visit, discontinued from the study or is lost to follow-up.
    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 months3
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days22
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    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 Decision2020-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-13
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