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    Summary
    EudraCT Number:2021-005774-25
    Sponsor's Protocol Code Number:SC104
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-18
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-005774-25
    A.3Full title of the trial
    A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors
    II. fázisú, nyílt, egykarú, multicentrikus vizsgálat a pembrolizumabbal együtt alkalmazott SOT101 hatásosságának és biztonságosságának értékelésére az előrehaladott/refrakter szolid tumorok különböző, meghatározott típusaiban szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate safety and efficacy of SOT101 in combination with pembrolizumab in patients with selected advanced/refractory solid tumors
    Vizsgálat a pembrolizumabbal együtt alkalmazott SOT101 hatásosságának és biztonságosságának értékelésére az előrehaladott/refrakter szolid tumorok különböző, meghatározott típusaiban szenvedő betegeknél
    A.4.1Sponsor's protocol code numberSC104
    A.5.4Other Identifiers
    Name:INDNumber:140011
    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 SponsorSOTIO Biotech AG
    B.1.3.4CountrySwitzerland
    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 supportSOTIO Biotech A.G.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOTIO Biotech a.s.
    B.5.2Functional name of contact pointClinical Trial SOTIO
    B.5.3 Address:
    B.5.3.1Street AddressJankovcova 1518/2
    B.5.3.2Town/ cityPrague 7
    B.5.3.3Post code170 00
    B.5.3.4CountryCzechia
    B.5.6E-mailclinicaltrial@sotio.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 nameSO-C101
    D.3.2Product code SO-C101
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRECOMBINANT HIL15-SUSHI+ FUSION PROTEIN
    D.3.9.1CAS number 1416390-27-6
    D.3.9.2Current sponsor codeSOT101
    D.3.9.3Other descriptive nameHuman interleukin-15 fused to interleukin-15 receptor subunit alpha Sushi+ domain
    D.3.9.4EV Substance CodeSUB246428
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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 nameMK-3475
    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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.3Other descriptive namePembrolizumab
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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/refractory solid tumors
    E.1.1.1Medical condition in easily understood language
    advanced/refractory solid tumors.
    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 10029514
    E.1.2Term Non-small cell lung cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level LLT
    E.1.2Classification code 10085908
    E.1.2Term Cutaneous squamous cell carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019829
    E.1.2Term Hepatocellular carcinoma recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033130
    E.1.2Term Ovarian cancer NOS
    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 estimate the antitumor efficacy of SOT101 in combination with pembrolizumab
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of SOT101 in combination with pembrolizumab according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. To further evaluate the antitumor efficacy of SOT101 in combination with pembrolizumab. (Population) pharmacokinetics (PK) of SOT101 in combination with pembrolizumab.To determine the immunogenicity of SOT101 in combination with pembrolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Be 18 years of age on the day of signing informed consent
    2.Ability to understand and sign written informed consent to participate in the study
    3.Provides written informed consent for the study
    4.Patients with the following histologically or cytologically confirmed solid tumor indications and line of treatment:
    •NSCLC
    •Colorectal cancer
    •cSCC
    •Advanced hepatocellular carcinoma
    • mCRPC
    •Ovarian cancer
    5.Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
    mCRPC: Patients with both measurable and non-measurable disease will be enrolled. At least 35 patients with measurable disease will be enrolled. Patients with no measurable disease and only widespread bone disease must have a CTC count of >5 cells per 7.5 mL of blood.
    6.Accessible tumor tissue available for fresh biopsy except for mCRPC with no accessible tumor tissue
    7.Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1
    8.Must have recovered from all AEs (except alopecia) due to previous therapies to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy
    Have adequate organ function as defined below. Specimens must be collected within 10 days prior to the start of study interventions.
    9.Hematology:
    9.1. Absolute neutrophil count ≥1500/µL
    9.2. Platelets ≥100 000/µL
    9.3. Hemoglobin ≥9.0 g/dL (criteria must be met without packed red blood cell transfusion within the prior 2 weeks; patients can be on a stable dose of erythropoietin [≥ 3 months])
    10.Renal function: Creatinine clearance as measured by glomerular filtration rate ≥30 mL/min using Cockcroft-Gault equation
    11.Hepatic function: Alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5× upper limit of normal (ULN) and total bilirubin ≤1.5×ULN or direct bilirubin ≤ ULN in patients without liver metastasis (benign hereditary hyperbilirubinemias). In patients with liver metastasis, ALT/AST ≤5×ULN is allowed but total bilirubin must be ≤2×ULN.
    12.Prothrombin time and activated partial thromboplastin time ≤1.5×ULN
    13.Patients who are hepatitis B (HBV) surface antigen positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load before study entry (ICF signature).
    14.Patients with history of hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening. Patients must have completed anti-viral therapy at least 4 weeks before study entry (ICF signature).
    15.A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
    15.1.Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for
    12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient.
    15.2.A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 120 days after the last dose of pembrolizumab or at least 30 days after the last dose of SOT101, whichever is later.
    • WOCBP can only be included after a negative serum pregnancy test at screening.
    • Highly effective contraception includes:
    o Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
     Oral
     Intravaginal
     Transdermal
    o Progestogen-only hormonal contraception associated with inhibition of ovulation:
    Oral
    Injectable
    Implantable
    oIntrauterine device
    oIntrauterine hormone-releasing system
    oBilateral tubal occlusion
    oVasectomized partner provided the partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.
    oSexual abstinence defined as refraining from heterosexual intercourse during the entire treatment period and for at least 120 days after the last dose of pembrolizumab or at least 30 days after the last dose of SOT101, whichever is later. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
    16. Male patients must agree to use a condom during the treatment period and for at least 120 days after the last dose of pembrolizumab or at least 30 days after the last dose of SOT101, whichever is later.
    E.4Principal exclusion criteria
    1.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a grade ≥3 AE
    2.Prior exposure to drugs that are agonists of IL-2 or IL-15
    3.Prior systemic anti-cancer therapies, including investigational agents, before study entry (ICF signature):
    3.1. Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter)
    3.2. Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery
    4.Has received prior radiotherapy within 2 weeks of the start of study interventions. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease.
    5.NSCLC indication only: Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study interventions
    6.Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study interventions
    Prior/concurrent clinical study experience
    7.Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or 5 half lives (whichever shorter) before study entry (ICF signature). Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks or 5 half lives (whichever shorter) after the last dose of the previous investigational agent.
    8.Clinically significant cardiac abnormalities including prior history of any of the following:
    8.1. Cardiomyopathy, with left ventricular ejection fraction ≤50% at screening
    8.2. Congestive heart failure of New York Heart Association grade ≥2
    8.3. History of clinically significant, atherosclerotic cardiovascular disease, specifically myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study interventions, and any history of coronary heart disease and clinically significant peripheral and/or carotid artery disease
    8.4.Prolongation of QTcF >450 msec
    8.5.Clinically significant cardiac arrythmia that cannot be controlled with adequate medication
    9.Uncontrolled hypertension defined as systolic blood pressure >160 mmHg, diastolic blood pressure >110 mmHg. Patients with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry (ICF signature).
    10. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
    11.Has had an allogeneic tissue/solid organ transplant
    12.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study interventions
    13.History of or serology positive for HIV
    14.Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Patients with basal cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded.
    15.Has known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study interventions.
    16.Has severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients
    17.Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    18. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    19.Has an active infection requiring systemic therapy
    20.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
    21.Has a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study
    E.5 End points
    E.5.1Primary end point(s)
    • Objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) in patients with measurable disease
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    Type, frequency, and severity of treatment-emergent adverse events (TEAEs); adverse events of special interest (AESIs); safety laboratory findings; vital signs; electrocardiography (ECG) findings; • ORR according to RECIST for immune-based therapeutics (iRECIST) (iORR) in patients with measurable disease
    • Best overall response according to RECIST 1.1 (BOR) and iRECIST (iBOR) in patients with measurable disease
    • Duration of response according to RECIST 1.1 (DoR), iRECIST (iDoR), and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1 (metastatic castration-resistant prostate cancer [mCRPC] only)
    • Clinical benefit rate according to RECIST 1.1 (CBR), iRECIST (iCBR), and PCWG3-modified RECIST 1.1 (mCRPC only)
    • Progression-free survival (PFS) according to RECIST 1.1, iRECIST (iPFS), and PCWG3-modified RECIST 1.1 (mCRPC only)
    • Time to response according to RECIST 1.1 (TtR) and iRECIST (iTtR) in patients with measurable disease
    • mCRPC only:
    o Circulating tumor cell (CTC) count conversion from >5 to <5 cells per 7.5 mL of blood
    o Confirmed prostate-specific antigen (PSA) decline of ≥50%
    o Time to confirmed PSA progression
    • Plasma concentrations of SOT101 over time;
    • Incidence, titer, and time course of anti-drug antibodies (ADAs) against SOT101
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 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.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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    United States
    France
    Poland
    Spain
    Czechia
    Italy
    Belgium
    Georgia
    Hungary
    United Kingdom
    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
    The study will end one year after the last patient’s last dose of SOT101 and/or pembrolizumab (whichever occurs later). A patient is considered to have completed the study if s/he has completed all phases of the study including the last follow-up contact
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days12
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 320
    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)
    N/A
    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 Decision2022-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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