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    Summary
    EudraCT Number:2018-003172-12
    Sponsor's Protocol Code Number:KY1044-CT01
    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:2022-07-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-003172-12
    A.3Full title of the trial
    A Phase 1/2, open-label, multi-center study of the safety and efficacy of
    KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2, open-label, multi-center study of the safety and efficacy of
    KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies
    A.4.1Sponsor's protocol code numberKY1044-CT01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03829501
    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 SponsorKymab Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportKymab Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKymab Ltd
    B.5.2Functional name of contact pointClinical trials information Kymab
    B.5.3 Address:
    B.5.3.1Street AddressThe Bennet Building (B930), Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailClinicaltrial@kymab.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 nameKY1044
    D.3.2Product code KY1044
    D.3.4Pharmaceutical form 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 INNalomfilimab
    D.3.9.2Current sponsor codeKY1044
    D.3.9.4EV Substance CodeSUB195238
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 Yes
    D.2.1.1.1Trade name Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAtezolizumab
    D.3.4Pharmaceutical form 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 INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44
    D.3.9.2Current sponsor codeTECENTRIQ
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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
    Advanced/metastatic malignancies, and preferred indications: head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal cancer, gastric cancer, melanoma, renal cell cancer, pancreatic cancer, cervical cancer, and triple negative breast cancer (BC)
    E.1.1.1Medical condition in easily understood language
    selected advanced malignancies
    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 10015362
    E.1.2Term Esophageal cancer
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077738
    E.1.2Term Hepatocellular carcinoma metastatic
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10033609
    E.1.2Term Pancreatic carcinoma
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10038389
    E.1.2Term Renal cancer
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10025650
    E.1.2Term Malignant melanoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007416
    E.1.2Term Carcinoma liver
    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
    Phase 1:
    To characterize the safety and tolerability of KY1044 as single agent and in combination with atezolizumab and to identify recommended doses for future studies.
    Phase 2:
    To estimate the anti-tumor efficacy of KY1044 as single agent and in combination with atezolizumab.
    E.2.2Secondary objectives of the trial
    - To evaluate the preliminary anti-tumor activity of KY1044 as single agent and in combination with atezolizumab (Phase 1 only)
    - To characterize the safety and tolerability of KY1044 as single agent and in combination with atezolizumab (Phase 2 only)
    - To characterize the PK profile of KY1044 as single agent and in combination with atezolizumab
    -To assess PK of atezolizumab in combination with KY1044
    - To assess emergence of anti-KY1044 and anti-atezolizumab antibodies following one or more i.v. infusions of KY1044 single agent and/or in combination with atezolizumab
    - To assess changes in biomarkers
    - To describe the survival rate at 12 and 24 months of patients treated with KY1044 as single agent and in combination with atezolizumab for each disease group
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained prior to any procedures
    2. Age ≥18 years (≥20 years in Taiwan)
    3. Histologically documented advanced/metastatic malignancies
    4. Phase 1 and Phase 2 patients with advanced/metastatic malignancies who have measurable disease (non-measurable disease is allowed only in Phase 1) as determined by RECIST 1.1 (refer to Appendix 2) will be eligible if, according to the NCCN guidelines, there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options. Additionally, the following specific tumor indications will be enrolled:
    a. Phase 1 (including enrichment part):
    Patients with advanced/metastatic malignancies, and preferred indications as identified in Section 3.1 (NSCLC, HNSCC, HCC, melanoma, cervical, gastric/esophageal, renal, pancreatic, and triple negative BC)
    b. Phase 2 KY1044 single agent:
    Patients with advanced/metastatic malignancies in indications in which signs of anti tumor activity (CR, PR or durable SD with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of KY1044 as single agent.
    c. Phase 2 KY1044 in combination with atezolizumab:
    Patients with advanced/metastatic malignancies in the below selected indications, and/or indications which have shown promising activity in Phase 1:
    • NSCLC (anti PD (L)1 therapy naïve and pre treated between 1 and 2 prior lines of systemic therapy for advanced disease)
    • Gastric/Esophageal (anti PD (L)1 therapy naïve and pre treated)
    • Recurrent and/or metastatic HNSCC (anti PD (L)1 therapy naïve and pre treated between 1 and 2 prior lines of systemic therapy for
    advanced disease)
    • Cervical (anti PD (L)1 therapy naïve and pre treated)
    Indications, in which signs of anti tumor activity has been observed in Phase 1 with KY1044 in combination with atezolizumab
    5. Prior therapy with anti-PD-(L)1 inhibitors is allowed provided any toxicity attributed to prior anti-PD-(L)1-directed therapy did not lead to discontinuation of therapy
    6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    7. Life expectancy longer than 12 weeks
    8. Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on the study
    9. Females of child bearing potential must be using two highly effective
    contraceptive measures for the duration of study participation and for at least 5 months after discontinuing study treatment, or longer if the half-life of KY1044 is observed to exceed that of atezolizumab (see Section 5.8).Females must not be breast feeding and must have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
    - Post-menopausal defined as aged ≥50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
    - Women less than 50 years old would be considered postmenopausal if they have been amenorrhoeic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone and luteinizing hormone levels in the postmenopausal range for the institution
    - Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
    10. For the duration of study participation and for at least 5 months after discontinuing study treatment, or longer if the half-life of KY1044 is observed to exceed that of atezolizumab, sexually active males must use barrier contraception (i.e., condoms).
    E.4Principal exclusion criteria
    1. Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks of first dose of study treatment. Patients with treated brain metastasis unless neurologically stable (for 4 weeks post-treatment and prior to study enrolment) and off of steroids for at least 2 weeks before the first dose of study treatment
    2. History of severe hypersensitivity to other mAbs and/or their excipients
    3. Known presence of neutralizing anti-atezolizumab antibodies (for patients previously treated with atezolizumab)
    4. Having out of range laboratory values (creatinine, bilirubin, ALT, AST, Absolute neutrophil count , Platelet count, Hemoglobin)
    5. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
    - Clinically significant and/or uncontrolled heart disease (congestive heart failure requiring treatment, uncontrolled hypertension or clinically significant arrhythmia)
    - QTcF >470 msec on screening ECG using Fridericia's formula (QTcF) or congenital long QT syndrome
    - Acute myocardial infarction or unstable angina pectoris <3 months prior to first dose of study treatment
    6. Known human immunodeficiency virus, active hepatitis B virus or active hepatitis C virus infection. Patients with any severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection.
    7. Malignant disease, other than that being treated in this study.
    8. Any medical condition that would, in the Investigator’s judgment, prevent the patient’s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
    9. Active autoimmune disease or a documented history of autoimmune disease
    10. Patients previously exposed to anti-PD-(L)1 treatment who are not adequately treated for skin rash or had no replacement therapy for endocrinopathies should be excluded
    11. Patients with a history of drug-induced pneumonitis or current pneumonitis
    12. Systemic steroid therapy or any immunosuppressive therapy. Topical, inhaled, nasal, and ophthalmic steroids are not prohibited
    13. Herbal preparations/medications (including, but not limited to: St. John’s Wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng) are prohibited from the time that patients enter the screening period (at least 7 days prior to first dose of study treatment) until the last dose of study treatment (3 weeks for St John’s Wort)
    14. Warfarin and other types of long acting anticoagulants (such as phenprocumon and or anti Xa inhibitors with a half life of >12 hours) is prohibited within 4 weeks of the first dose of study treatment and patients requiring anticoagulant treatment should switch to low molecular weight heparin or anti Xa inhibitors with a half life of ≤12 hours
    15. Use of live or live attenuated vaccines against infectious diseases within 4 weeks of the first dose of study treatment. SARS-CoV-2 vaccines are allowed (unless it is live or live attenuated) at least 7 days prior to the first dose.
    16. Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, 4 weeks is indicated as washout period
    17. Major surgery within 2 weeks of the first dose of study treatment
    18. Anti-CTLA4, anti-PD-(L)1 treatment within 4 weeks of the first dose of study treatment
    19. Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway
    20. Participation in an interventional, investigational study within 4 weeks of the first dose of study treatment
    21. Presence of CTCAE v5 ≥Grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if CTCAE v5 ≥Grade 3) due to prior cancer therapy
    22. Use of hematopoietic colony-stimulating growth factors ≤2 weeks prior to start of study treatment. An erythroid stimulating agent is allowed if it was initiated at least 2 weeks prior to the first study treatment dose and the patient is on a stable dose
    23. Radiotherapy within 2 weeks of the first dose of study treatment, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass. To allow evaluation for response to treatment, patients enrolled in the Phase 2 part must have remaining measurable disease that has not been irradiated.
    24. Pregnant or lactating women. In rare cases of an endocrine-secreting tumor, hCG levels may be above normal limits, but without existing pregnancy. In these cases, there should be a repeat serum beta-hCG test and a vaginal/pelvic ultrasound to rule out pregnancy. Upon confirmation of results and discussion with the Medical Monitor, these patients may enter the study.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    - Safety: Incidence and severity of AEs and SAEs, including changes in laboratory parameters, vital signs and electrocardiograms (ECGs)
    - Tolerability: Dose interruptions, reductions and dose intensity
    - The incidence of DLTs with KY1044 as single agent during the first 21 days of treatment
    - The incidence of DLTs with KY1044 in combination with atezolizumab during the first 21 days of treatment

    Phase 2
    - ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1
    Safety evaluation and assessment of AEs throughout the study
    Phase 2
    Tumor Imaging RECIST 1.1: at screening, every 8 weeks (±7 days) after the start of treatment for the first 16 weeks, after that every 12 weeks (±7 days) till the end of 48 months of treatment or until objective disease progression
    E.5.2Secondary end point(s)
    Efficacy measures:
    - Best Overall Response (BOR), PFS and Duration of Response (DOR) per RECIST 1.1;
    - ORR and PFS per immune-related (i)RECIST (Phase 1 and Phase 2)
    - ORR per RECIST 1.1 (Phase 1 only)
    - Survival rate at 12 and 24 months
    Safety:
    - Safety: Incidence and severity of AEs and SAEs, including changes in laboratory parameters, vital signs and ECGs (Phase 2)
    -Tolerability: Dose interruptions, reductions and dose intensity (Phase 2)
    PK measures: Serum concentrations and PK parameters (eg, Cmax, t1/2) of KY1044 and of atezolizumab if in combination
    Anti-drug antibodies: Presence and/or concentration of anti-KY1044 and anti-atezolizumab antibodies
    Biomarkers:Presence of tumor-infiltrating lymphocytes (TILs) as determined by expression of inducible T cell costimulator (ICOS), Forkhead box P3 (FOXP3) and CD8 cells (immunohistochemistry)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy measures:
    - Tumor Imaging RECIST 1.1: at screening, every 8 weeks after the start of treatment for the first 16 weeks, after that every 12 weeks till the end of 48 months of treatment or until objective disease progression
    Safety:
    - Safety evaluation and assessment of AEs throughout the study
    - Tolerability assessed throughout the study
    PK measures; PK samples will be taken pre- and post-dose during all cycles and unscheduled at any time, when clinically indicated
    Anti-drug antibodies; ADA samples are collected at every cycle at pre-dose on Day 1 and unscheduled at any time, when clinically indicated
    Biomarkers
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 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 trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Taiwan
    United States
    Poland
    Czechia
    Italy
    Hungary
    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
    The completion of the study is defined as the last visit for the last patient on treatment (for patients, who stopped treatment earlier follow-up will be ended at this point).
    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 months6
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years5
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 82
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 412
    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)
    Additional provisions for treatment continuation may be made for patients who are ongoing on treatment and having clinical benefit at 48 months for continuation of treatment.
    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 Decision2023-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
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