Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005575-12
    Sponsor's Protocol Code Number:BYON5667.002
    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:2021-05-07
    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 number2020-005575-12
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled trial with a single arm run-in period to evaluate the safety and efficacy of sodium thiosulfate (BYON5667) eye drops to reduce ocular toxicity in cancer patients treated with SYD985.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of BYON5667 eye drops to reduce ocular toxicity in cancer patients treated with SYD985.
    A.4.1Sponsor's protocol code numberBYON5667.002
    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 B.V.
    B.1.3.4CountryNetherlands
    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 B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationByondis B.V.
    B.5.2Functional name of contact pointClinical Project Leader
    B.5.3 Address:
    B.5.3.1Street AddressMicroweg 22
    B.5.3.2Town/ city Nijmegen
    B.5.3.3Post code6545 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 24 679 5100
    B.5.6E-mailEllen.mommers@byondis.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 vc-seco-DUBA
    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.3.9.4EV 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.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 No
    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.3.11.13.1Other medicinal product typeAntibody-drug conjugate (ADC)
    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 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 nameSodium Thiosulfate Pentahydrate
    D.3.2Product code BYON5667
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Applicable
    D.3.9.1CAS number 10102-17-7
    D.3.9.2Current sponsor codeBYON5667
    D.3.9.3Other descriptive nameSODIUM THIOSULFATE PENTAHYDRATE
    D.3.9.4EV Substance CodeSUB22204
    D.3.10 Strength
    D.3.10.1Concentration unit mol/l mole(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.1 to 0.2
    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) No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Single arm run-in period: Patients with solid tumours (excluding gastric tumours and adenocarcinomas of the gastroesophageal junction)
    Randomized part of the study: patients with locally advanced or metastatic HER2-positive breast cancer
    E.1.1.1Medical condition in easily understood language
    Advanced or Metastatic 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 LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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
    • Safety and tolerability of BYON5667 eye drops administered up to 6-times daily by assessing incidence and severity of BYON5667-related AEs;
    • Efficacy of BYON5667 eye drops by assessing the percentage of patients with SYD985-related ocular toxicity Grade ≥1 at Day 63.
    E.2.2Secondary objectives of the trial
    • Tolerability of BYON5667 eye drops by means of Eye Drop Tolerability questionnaire scores;
    • National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) scores;
    • Percentage of patients with SYD985-related ocular toxicity Grade ≥2 and Grade ≥3 at Day 63;
    • Percentage of patients with SYD985-related ocular toxicity Grade ≥1, Grade ≥2, and Grade ≥3 at Day 126;
    • Time to first SYD985-related ocular AE of Grade ≥1, Grade ≥2, and Grade ≥3;
    • Percentage of patients who discontinued SYD985 treatment due to SYD985-related ocular toxicity;
    • Efficacy of SYD985 by assessing the objective response rate (ORR), progression-free survival (PFS), and overall survival;
    • Safety of SYD985
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age ≥18 years at the time of signing first informed consent;
    2. Patient with histologically-confirmed, unresectable locally advanced or metastatic cancer with the following restriction:
    Single arm part: patient with solid tumours of any origin (excluding gastric tumours and adenocarcinomas of the gastroesophageal junction) who has progressed on standard therapy or for whom no standard therapy exists;
    Randomized part: patient with breast cancer who had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease, or progression during or after [ado-]trastuzumab emtansine treatment for locally advanced or metastatic disease;
    3. HER2 tumour status as determined by a local laboratory using immunohistochemistry (IHC) and/or in situ hybridization (ISH):
    Single arm part: at least IHC 1+;
    Randomized part: IHC 3+ and/or ISH positive;
    4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
    5. Patient should be able to self-administer eye drops up to 6-times daily or should have adequate daily assistance available (e.g. caregiver) to administer the eye drops;
    6. Patient should refrain from wearing any kind of contact lenses during trial treatment;
    7. Adequate organ function, evidenced by the following 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 and male patients with a female partner of childbearing potential, highly effective contraception must be used during the trial and up to at least 6 months after last IMP 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
    Exclusion criteria
    1. Having been treated with:
    a. DUBA-containing antibody-drug conjugates (ADCs) at any time;
    b. Anthracycline treatment within 8 weeks prior to start SYD985 treatment;
    c. Other anticancer therapy including chemotherapy, immunotherapy, or investigational agent within 4 weeks prior to start SYD985 treatment or within 5 times the half-life of the therapy, whatever is shorter;
    d. Radiotherapy within 4 weeks prior to start SYD985 treatment, or within 1 week for palliative care (as long as the lungs were not exposed);
    e. Hormone therapy (except for luteinizing hormone-releasing hormone agonists for prostate cancer or premenopausal breast cancer) within 1 week prior to start SYD985 treatment;
    The patient must have sufficiently recovered from any treatment-related toxicities to CTCAE Grade ≤1 or baseline, 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 containing treatment or excipients of the trial treatments which led to permanent discontinuation of the treatment;
    3. History or presence of keratitis;
    4. 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 trastuzumab containing treatment leading to permanent discontinuation of treatment;
    5. History or presence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan;
    6. History (within 6 months prior to start SYD985) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication;
    7. Severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) at screening;
    8. Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to start SYD985 treatment;
    9. Positive COVID-19 test within 8 weeks prior to start SYD985 treatment, presence of clinically significant symptoms of confirmed or unconfirmed suspected COVID-19 infection at screening (regardless if and when patient was tested), presence of COVID-19 related signs on screening chest CT scan, or need for continued supportive medication for past COVID-19 infection;
    10. Known active Hepatitis B, C or E infection at screening;
    11. Major surgery within 4 weeks prior to start SYD985 treatment;
    12. Pregnancy or lactation;
    13. Other condition, which in the opinion of the investigator, would compromise the safety of the patient or the patient’s ability to complete the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoint of this trial is:
    • Incidence and severity of BYON5667-related AEs.

    The primary efficacy endpoint of this trial is:
    • Percentage of patients with SYD985-related ocular toxicity Grade ≥1 at Day 63.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study assessments and procedures will be performed as outlined in the Protocol (Trial Flow Chart).

    The first primary efficacy analysis will be performed when 20 patients completed the Day 63 assessments (i.e. Cycle 4 Day 1 visit), or discontinued due to SYD985-related ocular toxicity prior to this visit. It is anticipated that an overall analysis for the single arm part of the trial will be performed when all patients completed the Day 126, i.e. after completion of approximately 4 months of treatment, or have discontinued prematurely.
    E.5.2Secondary end point(s)
    The secondary safety endpoints of this trial are:
    • Incidence and severity of (serious) AEs;
    • Eye Drop Tolerability questionnaire scores;
    • National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores;
    • Percentage of patients who discontinued SYD985 treatment due to SYD985-related ocular toxicity;
    • Changes in vital signs and weight;
    • Changes in ophthalmological examination and laboratory parameters;
    • Number of patients with SYD985 dose modifications due to AEs.

    The secondary efficacy endpoints of this trial are:
    • Percentage of patients with SYD985-related ocular toxicity Grade ≥2 and Grade ≥3 at Day 63;
    • Percentage of patients with SYD985-related ocular toxicity Grade ≥1, Grade ≥2, and Grade ≥3 at Day 126;
    • Time to first SYD985-related ocular AE of Grade ≥1, Grade ≥2, and Grade ≥3;
    • Objective response rate (ORR);
    • Progression-free survival (PFS);
    • Overall survival.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study assessments and procedures will be performed as outlined in the Protocol (Trial Flow Chart).
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 trial to evaluate the safety of BYON5667 eye drops in cancer patients treated with SYD985
    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 Yes
    E.8.1.7.1Other trial design description
    Randomized, double-blind, placebo-controlled trial with a single arm run-in period
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned4
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 trial ends when the last patient completed the 30-days follow-up visit, discontinued from the trial 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 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 months0
    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: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 205
    F.4.2.2In the whole clinical trial 205
    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 Decision2021-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 02:57:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA