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    Summary
    EudraCT Number:2021-000423-12
    Sponsor's Protocol Code Number:CP506-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000423-12
    A.3Full title of the trial
    A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic Hypoxia Activated Prodrug in patients with HRD/FAD solid tumours or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumour and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial.
    Fase 1-2a klinische studie van door hypoxie geactiveerde prodrug CP-506 monotherapie of met carboplatin of met ICI in een met HRD verrijkte populatie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1-2a clinical trial for CP-506 that is a drug specific for solid tumours and is activated at low concentrations of oxygen. The trial has 3 modules and 2 parts for each module. Module 1, part A is a dose increase of CP-506 with the possibility to enrol more patients on part B once the recommended phase 2 dose has been determined. Module 2 is the same as module 1 but combining CP-506 with carboplatin and module 3 is combining CP-506 with one Immune Checkpoint Inhibitor.
    Fase 1-2a klinische studie voor CP-506, een geneesmiddel dat specifiek is voor solide tumoren en wordt geactiveerd bij lage zuurstofconcentraties. De proef heeft 3 modules en 2 delen voor elke module. Module 1, deel A is een dosisverhoging van CP-506 met de mogelijkheid om meer patiënten in te schrijven voor deel B zodra de aanbevolen fase 2-dosis is bepaald. Module 2 is hetzelfde als module 1, maar het combineren van CP-506 met carboplatine en module 3 is het combineren van CP-506 met één ICI.
    A.3.2Name or abbreviated title of the trial where available
    TUMAGNOSTIC (CP506-001)
    A.4.1Sponsor's protocol code numberCP506-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04954599
    A.5.4Other Identifiers
    Name:CCMO - NetherlandsNumber:NL78163.068.21
    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 SponsorMaastricht University
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Commission
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointJorge Ramos de Almeida
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 40, room 4.531
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229ER
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31617752850
    B.5.6E-mailj.ramosdealmeida@maastrichtuniversity.nl
    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 nameCP-506
    D.3.2Product code CP-506
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNMethanone methane sulfonic acid salt
    D.3.9.1CAS number 2227304-19-8
    D.3.9.2Current sponsor codeCP-506
    D.3.9.3Other descriptive nameMethanone, [5-[(2-bromoethyl)[2-[(methylsulfonyl)oxy]ethyl]amino]-4-(methylsulfonyl)-2-nitrophenyl](4-ethyl-1-piperazinyl)-, methane sulfonic acid salt
    D.3.9.4EV Substance CodeSUB216974
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Tumour Agnostic treatment.
    ● Module differentiation:
    – Module 1 - monotherapy – solid tumour patients with cancer types that are enriched for HRD/FAD defects
    – Module 2 – combination with Carboplatin – solid tumour patients with cancer types that are enriched for HRD/FAD defects
    – Module 3 – combination with SOC ICI– solid tumour patients with oligoprogressive disease receiving immune-checkpoint inhibitor (ICI) as standard of care
    E.1.1.1Medical condition in easily understood language
    Patients with a solid cancer that has particular genetic mutations which makes it particularly sensitive to CP-506.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10084788
    E.1.2Term HRD positive advanced ovarian 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 LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic 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 10067821
    E.1.2Term Head and neck 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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 10060862
    E.1.2Term Prostate cancer
    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
    1.Incidence of treatment-emergent adverse events including dose-limiting toxicities
    The proportion of patients with treatment-emergent (serious) adverse events including dose-limiting toxicity (DLT)

    [Time Frame: Baseline until 60 days after last administration of CP-506]

    2.Incidence of clinically significant abnormal measurements in physical examination, vital signs, electrocardiogram (ECG), lab tests and ECOG performance status
    Physical examination; vital signs; electrocardiogram (ECG); haematology; clinical chemistry; urinalysis; plasma/renal makers; tumour markers; ECOG performance status

    [Time Frame: Baseline until 60 days after last administration of CP-506]
    E.2.2Secondary objectives of the trial
    Characterization of the pharmacokinetics (PK) and pharmacodynamics (PD)
    Measurement of CP-506 levels in plasma over time to calculate Cmax. AUC of CP-506 plasma concentration
    [Time Frame: Before administration of CP-506 up to day 4 after initial treatment on cycle 1]
    Determine the minimal biological effective dose
    Dose that results in 1) a decrease of 20% of hypoxia radiomics score on sequential CT of at least one lesion OR 2) a decrease of 20% of the initial tumour volume of at least one lesion
    [Time Frame: Baseline until 60 days after last administration of CP-506]

    Efficacy of CP-506
    (RECIST) using automated volumetric analysis of all the measurable lesions (aRECIST):
    Time to response
    Duration of response - the time from documentation of tumour response to disease progression
    Assessment of stabilization of disease, using waterfall plots. DRR will be combined with stable disease (SD) to produce a DCR
    Overall survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    Inclusion Criteria:

    Male or female, aged 18 years or more at the time of signing the informed consent
    Be willing and able to provide written informed consent for the trial
    Life expectancy of at least 6 months
    Be willing to have a biopsy collection procedure
    ECOG Performance status <= 2
    Must have adequate organ and bone marrow function, defined as the following:

    6.1. ANC ≥ 1500 µL 6.2. Hemoglobin ≥ 9.0 g/dL 6.3. Platelets ≥ 100 000 µL 6.4. Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN 6.5. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) 6.6. Creatinine ≤ 1.5 × ULN 6.7. Coagulation: INR ≤ 1.5 × ULN (or within therapeutic ranges for participants on anticoagulant treatment)

    Measurable disease on CT scan (RECIST 1.1)
    If female, not pregnant, not breastfeeding, and at least one of the following conditions applies:

    8.1. Not a woman of childbearing potential (WOCBP) 8.2. A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment and shows a negative pregnancy test before the start of the treatment

    If male, must agree to use contraception during the treatment period and for at least 4 weeks after the last dose of study treatment
    Able and willing to comply with the protocol Module 1 - monotherapy
    Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available
    Have indications of Homologous Recombination (HR) or Fanconi Anaemia (FA) DNA damage repair defects, based on hereditary cancer diagnostics (e.g. BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsies. Presence of such a defect must have been established via a tissue based next generation sequencing test, performed --in a CAP/CLIAcertified (or comparable local or regional certification) laboratory, or via a germline test from one of the following approved providers: Myriad Genetics; Invitae; Ambry; Quest; Color Genomics; MSKCC-IMPACT; GeneDx; Foundation Medicine OR Have cancers with an increased incidence of HRD/FAD: ovarian (41%), breast (18%), pancreas (10%), prostate (9%), and head and neck (5%) OR Patients who were previously responsive to alkylating agent (Partial Response/Complete Response according to RECIST criteria).

    Module 2 - Carboplatin combination

    Patient must be eligible to carboplatin treatment.
    Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available.
    Have indications of Homologous Recombination (HR) or Fanconi Anaemia (FA) DNA damage repair defects based on hereditary cancer diagnostics (e.g. BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsies; or have cancers with an increased incidence of HRD/FAD: ovarian (41%), breast (18%), pancreas (10%), prostate (9%), and head and neck (5%) or patients who were previously responsive to alkylating agent (Partial Response/Complete Response according to RECIST criteria) but the treatment has been discontinued due to toxicity.

    Module 3 - ICI combination

    Have histologically or cytologically-confirmed advanced or metastatic solid tumour
    Receiving immune checkpoint inhibitor (ICI) monotherapy as standard of care for at least 6 months prior to the beginning of the study and who are oligoprogressive. Oligoprogression disease is defined as localized treatment failure at one or two anatomic sites, with one to five progressive and measurable (according to RECIST 1.1) lesions, either new or with ≥ 20% growth of their longest diameter (short-axis in lymph nodes), while other tumor manifestations could shrink or grow less than 20% in diameter
    E.4Principal exclusion criteria
    Core:

    Prior radiotherapy to more than 25% of bone marrow
    Not recovered from all acute toxic effects of prior anticancer therapy (excluding CTCAE Grade 1 alopecia or peripheral neuropathy)
    Patients with significant cardiac co-morbidity, such as NYHA Class III or IV CHF, unstable angina, MI within the previous 6 months, or ventricular arrhythmias requiring drug therapy, pacemaker or implanted defibrillator. Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third-degree atrioventricular block. This does not apply to patient with a pace maker.
    Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting. Congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system.
    Symptomatic pericarditis
    A marked baseline prolongation of QT/QTc interval (> 450 ms)
    History of risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT syndrome)
    Use of concomitant medication prolonging the QT/QTc interval
    Evidence of uncontrolled infection or infection requiring a concomitant parenteral antibiotic
    Evidence of any other significant clinical disorder or laboratory finding
    Patients with a diagnosis (or strong suspicion) of a rare genetic disorder related to germline biallelic HR/FA and DNA repair gene mutations, such as Fanconi anemia patients of any subtype, Ataxia telangiectasia, Xeroderma pigmentosum, Cockayne, Nijmegen breakage, Werner and Bloom syndrome patients
    Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study
    Patient has been treated with any investigational drug or investigational therapeutic device within 30 days (60 days in case of biological compound) of initiating study treatment
    Less than 4 weeks since prior major surgery
    Known positive for HIV, Hepatitis B surface antigen positive or Hepatitis C positive with abnormal liver function tests
    Known allergy to alkylating agents
    Central nervous system (CNS) metastases, with the following exception:
    Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization.
    Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below:
    Autoimmune disease (current or history; refer to Table 19) or syndrome that required systemic treatment within the past 2 years
    Has a diagnosis of immunodeficiency or is receiving systemic steroids (>10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization Note:
    Receipt of any live vaccine within 30 days prior randomization
    Prior allogeneic/autologous bone marrow or solid organ transplantation
    Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents
    Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
    Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intraabdominal abscess
    Recent history of allergen desensitization therapy within 4 weeks of randomization
    Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Note: Stable non-cirrhotic, chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria
    Known history of active tuberculosis
    Any psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator

    Module 1 - monotherapy
    Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion

    Module 2 - Carboplatin combination
    Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion with exclusion of carboplatin.

    Module 3 - ICI combination

    Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion with exception of ICI
    Patients progressive under ICI justifying the immediate discontinuation of ICI
    Patients who would not receive further treatment with ICI as standard of care
    Patients with Complete Response under ICI
    E.5 End points
    E.5.1Primary end point(s)
    15.1 SAFETY ENDPOINTS
    The following safety parameters will be assessed:
    • Physical examination, vital signs, and ECOG performance status
    • 12-lead ECG
    • Laboratory parameters: Haematology, coagulation, clinical chemistry, serum renal markers, urinalysis, urine renal markers, and tumour markers (patients with relevant tumour types)
    • Number of DLTs
    • AEs (graded by (88)) (including pregnancy)
    • Number of withdrawals, discontinuations and dose reductions
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, 2, 3, 4, 14, 22, 23, 24, 25, 35, 43, 44, 45, 46, 57, 64, 105
    E.5.2Secondary end point(s)
    14.1 EFFICACY ENDPOINTS
    Efficacy Endpoints for Part A and Part B:
    - Tumour response defined as:
    • Partial or Complete Response (RECIST 1.1), providing Objective Response Rate (ORR), Durable Response Rate (DRR) and Overall Survival (OS)
    Pharmacokinetic Endpoints - Module 1A
    - MBED: Minimal biological effective dose will be measured by CT scan. It corresponds to the dose that results in 1) a decrease of 20% of hypoxia radiomics score on sequential CT of at least one lesion OR 2) a decrease of 20% of the initial tumour volume of at least one lesion.
    - Dose linearity of PK parameters for doses up to and beyond MBED
    Pharmacodynamic Endpoints
    - Tumour tissue Proof of Principle
    • Reduction of tumor lesion hypoxic fraction.
    • Reduction of tumor lesion size.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, 2, 3, 4, 14, 22, 25, 35, 43, 46, 57, 64, 105
    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 Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Modular
    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.8.3 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 EEA4
    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 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
    LVLS
    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 months0
    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 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: 126
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state126
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 126
    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
    Geen
    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 Decision2021-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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