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    Summary
    EudraCT Number:2021-003768-29
    Sponsor's Protocol Code Number:DAY101-102
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-003768-29
    A.3Full title of the trial
    A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination with Other Therapies for Patients with Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/2 study to Test Effects of Using DAY101 Monotherapy or Combination in patients with Solid Tumors Harboring MAPK Pathway Aberrations
    A.4.1Sponsor's protocol code numberDAY101-102
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/050/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDay One Biopharmaceuticals, Inc. (Day One)
    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 supportDay One Biopharmaceuticals, Inc. (Day One)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParexel International (IRL) Limited
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street Address70 Sir John Rogerson's Quay
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code2
    B.5.3.4CountryIreland
    B.5.6E-mailclinicaltrial.enquiries@parexel.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 nameDAY101
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtovorafenib
    D.3.9.1CAS number 1096708-71-2
    D.3.9.2Current sponsor codeDAY101
    D.3.9.3Other descriptive nameMLN2480, TAK-580, BSK1369, BIIB024
    D.3.9.4EV Substance CodeSUB89679
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 nameDAY101
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtovorafenib
    D.3.9.1CAS number 1096708-71-2
    D.3.9.2Current sponsor codeDAY101
    D.3.9.3Other descriptive nameMLN2480, TAK-580, BSK1369, BIIB024
    D.3.9.4EV Substance CodeSUB89679
    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) 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 namePimasertib
    D.3.2Product code DAY201
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPimasertib
    D.3.9.1CAS number 1236361-78-6
    D.3.9.2Current sponsor codeDAY201/MSC1936369B
    D.3.9.3Other descriptive namePIMASERTIB HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB129490
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 namePimasertib
    D.3.2Product code DAY201
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPimasertib
    D.3.9.1CAS number 1236361-78-6
    D.3.9.2Current sponsor codeDAY201/MSC1936369B
    D.3.9.3Other descriptive namePIMASERTIB HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB129490
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations
    E.1.1.1Medical condition in easily understood language
    Brain tumor in children
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b
    The Phase 1b objectives will apply to the investigation of DAY101 in combination with other therapies. Additional objectives may be specified according to the related sub-study protocol.
    Primary Objective:
    • To determine the safety of DAY101 in combination with other therapies.
    • To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of DAY101 in combination with other therapies.

    Phase 2
    The Phase 2 objectives will apply to the investigation of DAY101 as monotherapy and in combination with other therapies. Additional objectives may be specified according to the relevant sub-study protocol.
    Primary Objective:
    To evaluate the efficacy of DAY101 by RECIST version 1.1 or appropriate tumor response criteria as a monotherapy or in combination with other therapies
    E.2.2Secondary objectives of the trial
    Phase 1b:
    To assess the efficacy of DAY101 in combination with other therapies by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    To characterize the pharmacokinetic (PK) profile of DAY101 in combination with other therapies
    To characterize pharmacodynamic (PD) effects of DAY101 in combination with other therapies
    Phase 2:
    •To assess the safety and tolerability of DAY101 as monotherapy or in combination with othertherapies.
    •To assess additional efficacy parameters of DAY101 as monotherapy or in combination with othertherapies.
    •To characterize the tumor responses observed with DAY101 as monotherapy or in combination withother targeted therapies.
    •To characterize the PK profile of DAY101 in combination with other therapies, according to therelevant sub-study protocol.
    •To characterize the PD effects of DAY101 as monotherapy or in combination with other therapies.
    •To determine the relationship between PK and PD of DAY101 in combination with other therapies.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-Study 1:
    Clinical Protocol DAY101-102a (Monotherapy Substudy): A Phase 2, Subprotocol of DAY101 Monotherapy for Patients with Recurrent, Progressive, or Refractory Solid Tumors with Activating BRAF Gene Fusion.
    Amendment 2.0 dated 19-Oct-2022

    Sub-Study 2:
    Clinical Protocol DAY101-102b (Combination Therapy Sub-study): A Phase 1b/2, Subprotocol of DAY101 in Combination with Pimasertib for Patients with Recurrent, Progressive, or Refractory Solid Tumors and MAPK Pathway Aberrations
    Amendment 1.0 dated 19-Oct-2022
    E.3Principal inclusion criteria
    Master Protocol:
    Eligibility criteria can be found within each sub-protocol.

    Sub study :
    1. Signed informed consent by patients ≥ 12 years of age; either a Consent or an Assent Form will be provided to the patient based on their capacity, local regulations, and guidelines.
    2. Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplifications obtained through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted
    molecular diagnostic method recognized by local laboratory or regulatory agency
    3. Patients must have radiographically documented recurrent or radiographically documented progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1, RANO). Imaging must be performed within 28 days prior to the first dose of study drug .
    4. Patients must have progressed after and are not suitable for standard of-care treatment, including locally directed therapy, such as surgery or radiotherapy, prior to documented radiographic progression.
    5. Archival tumor tissue should be preferably less than 3 years old. If unavailable, a freshly acquired tumor tissue or liquid biopsy obtained at baseline to confirm presence of MAPK alteration is required.
    6. Previous chemotherapy and hormone therapy (excluding physiologic replacement) must be completed at least 4 weeks or 5 half-lives, whichever occurs first, prior to initiation of therapy.
    7. Previous immunotherapy/monoclonal antibody/targeted therapy use must be completed at least 2 weeks or 5 half-lives (whichever is shorter) prior to initiation of therapy. In addition, radiation therapy to the target lesion must be completed at least 6 months prior to initiation of therapy.
    8. All associated toxicity from previous therapies must be resolved to ≤ Grade 1 or considered baseline prior to initiation of therapy.
    9. If brain metastases are present, they must have been previously treated and be stable by radiographic imaging (must have imaging taken ≥ 4 weeks from treatment of brain metastasis) AND, if receiving corticosteroids, the patient must be neurologically stable by clinical examination and on a stable or a decreasing dose of corticosteroids within 7 days prior to study start.
    10. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1; For patients <16 years of age, a Lansky Performance Score > 70.
    11. Acceptable end-organ function as demonstrated by the following laboratory values
    12. Thyroid function tests must be consistent with stable thyroid function. Patients must be on a stable dose of thyroid replacement therapy for a minimum of 3 weeks before starting study drug.
    13. Left ventricular ejection fraction (LVEF) ≥ 50% or greater, as measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) within 28 days before the first dose of study drug.
    14. Ability to comply with outpatient treatment, laboratory monitoring, required clinic visits, and required imaging studies for the duration of study participation.
    15. Willingness of male and female patients with reproductive potential to use double highly effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 180 days following the last dose of study drug. Highly effective birth control methods are described in Appendix F of the Master
    Protocol.
    16. Male patients must agree not to donate sperm during the course of this study or within 180 days after receiving their last dose of study drug.
    See substudy Protocol A and substudy Protocol B
    E.4Principal exclusion criteria
    Master Protocol:
    Eligibility criteria can be found within each sub-protocol.
    Sub study Protocol A:
    1. Prior receipt of any RAS-, RAF-, MEK-, or ERK-directed inhibitor therapy.
    2. Known presence of concurrent activating alterations. Examples include, but are not limited, to the following: EGFR, ALK, MET, ROS, FGFR, RET, NTRK, PIK3CA, IDH1/2, and cKIT. Genomic profile of tumor under study will be reviewed by the Sponsor to confirm eligibility.
    3. Current enrollment in any other investigational treatment study.
    4. Patients with current evidence or a history of serous retinopathy (SR), retinal vein occlusion (RVO), or ophthalmopathy present at screening or baseline who would be considered at risk for SR or RVO.
    5. Patients who have an unstable neurological condition, despite adequate treatment (e.g., uncontrolled seizures).
    6. Evidence of current uncontrolled cardiovascular conditions, including but not limited to clinically significant cardiac arrythmias (such as ventricular arrhythmias, atrial fibrillation or recent recovery of rhythm after atrial fibrillation, bradycardia), congestive heart failure, angina, ischemia or myocardial infarction ventricular hypertrophy,
    cardiomyopathy, conduction disorder, or cerebrovascular accident (CVA), within the past 6 months.
    see protocol

    Sub protocol B
    1. Prior receipt of any Type-II pan-RAF inhibitor therapy (e.g., LXH254/naporafenib, BGB-283, BGB-3245, belvarafenib).
    2. Concomitant medications that are strong inhibitors or inducers of CYP2C8 and CYP2C19 within 14 days before initiation of therapy. Concomitant medications that are substrates of breast cancer resistance protein (BCRP) with a narrow therapeutic index within 14 days before initiation of therapy.
    3. Known presence of concurrent activating alterations. Examples include, but are not limited, to the following: EGFR, ALK, MET, ROS, RET, FGFR, NTRK, PIK3CA, IDH1/2, and cKIT. Genetic profile of tumor under study, will be reviewed by the Sponsor to confirm eligibility.
    4. Current enrollment in any other investigational treatment study.

    see protocol
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b:
    • Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Advanced Tumours (NCI CTCAE) v5
    • Change from baseline in targeted vital signs
    • Change from baseline in targeted clinical laboratory test results
    • Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5
    • Change from baseline in targeted vital signs
    • Change from baseline in targeted clinical laboratory test results
    • Incidence of dose-limiting toxicities (DLTs)

    Phase 2:
    Overall response rate (ORR) as assessed by the proportion of patients with the best overall confirmed response of complete response (CR) or PR according to the appropriate response assessment criteria for the disease setting as assessed by the Investigator.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    Phase 1b:
    • ORR as assessed by the proportion of patients with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate tumor response criteria as assessed by Investigator
    • Duration of response (DOR) in patients with best overall response of CR or PR as determined by the treating Investigator [from time of first tumor response to progression or date of data analysis, whichever occurs earlier]
    • Duration of progression-free survival (PFS) following initiation of study treatment to disease progression, death, or date of analysis, whichever occurs earlier
    • Duration of overall survival (OS) following initiation of study treatment to time of death
    • Time to response (TTR) in patients with best overall response of CR or PR as determined by treating Investigator [from initiation of study treatment to date of first response]
    • Comparing the DOR in patients with CR or PR as determine by treating Investigator with the DOR observed with the immediate prior line of anticancer treatment
    • Plasma concentration of DAY101 at specified time points in order to define PK parameters
    • Measured by downstream MAPK pathway signaling, including pERK and other relevant pathway signaling using appropriate assay(s) on tumor biopsies obtained at baseline and on Cycle 1 Day 1 and Cycle 2 Day 1 (± 3 days)

    Phase2:
    • Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5
    • Change from baseline in targeted vital signs
    • Change from baseline in targeted clinical laboratory test result
    • ORR as assessed by the proportion of patients with the best overall confirmed response of complete response (CR) or PR according to the appropriate tumor response criteria as assessed by Investigator
    • DOR in patients with best overall response of CR or PR as determined by the treating Investigator [from time of first tumor response to progression or date of data analysis, whichever occurs earlier]
    • Duration of progression-free survival (PFS) following initiation of study treatment to disease progression, death, date of analysis, whichever occurs earlier
    • Duration of OS following initiation of study treatment to time of death
    • Time to response (TTR) in patients with best overall response of CR or PR as determined by treating Investigator [from initiation of study treatment to date of first response]
    • Comparing the DOR in patients with CR or PR as determine by treating Investigator with the DOR observed with the immediate prior line of anticancer treatment]
    • Measure plasma concentration of DAY101 at specified time points in order to define population PK parameters
    • Measured by downstream MAPK pathway signaling and other relevant pathway signaling using appropriate assay(s) on tumor biopsies obtained at baseline and while on-treatment
    • Measured by the relationship between PK and PD biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    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 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 1b will only apply to sub-studies of DAY101 in combination with other therapies
    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 Yes
    E.8.1.7.1Other trial design description
    multi-center, umbrella
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Korea, Republic of
    United States
    France
    Spain
    Belgium
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 Yes
    F.1.1Number of subjects for this age range: 39
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 39
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 129
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Young children not of age to provide consent. Parents/guardians may give consent on behalf of their children.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 168
    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 Decision2022-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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