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    Clinical Trial Results:
    A Phase II Open-Label, Randomized Study of Immunoconjugate L-DOS47 in Combination with Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients with Lung Adenocarcinoma

    Summary
    EudraCT number
    		 2016-003015-34
    Trial protocol
    		 PL   HU  
    Global end of trial date
    06 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Aug 2024
    First version publication date
    28 Aug 2024
    Other versions
    Summary report(s)
    		 LDOS003

    Trial information

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    Trial identification
    Sponsor protocol code
    LDOS003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03891173
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helix BioPharma Corp.
    Sponsor organisation address
    Bay Adelaide Centre - North Tower, 40 Temperance Street, Suite 2700, Toronto, Canada, M5H 0B4
    Public contact
    Chief Executive Officer, Helix BioPharma Corp., 1 6046842181, jantas@helixbiopharma.com
    Scientific contact
    Clinical Operations, Helix BioPharma Corp., 1 4168092101, blee@helixbiopharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine: • Safety and tolerability of L-DOS47 in combination treatment with vinorelbine/cisplatin • Dose limiting toxicities (DLTs) of L-DOS47 in combination treatment with vinorelbine/cisplatin • Maximum tolerated dose (MTD) and recommended Part 2 dose of L-DOS47 in combination treatment with vinorelbine/cisplatin • Preliminary efficacy of L-DOS47 by comparing the time to disease progression (TTP) of L-DOS47 in combination with vinorelbine/cisplatin to vinorelbine/cisplatin alone in patients with lung adenocarcinoma
    Protection of trial subjects
    In the dose escalation portion of the trial, patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort. Decision on whether to escalate to the next dose level was made only after all the subjects in the cohort had completed the dose limiting toxicity evaluation period and the safety data were reviewed by the Trial Steering Committee. In order to monitor and assess for possible infusion reactions and/or allergic reactions, patients remained on site for a minimum of two hours from the start of the L-DOS47 infusion. Only when the maximum tolerated dose was determined could the study proceed to the randomised portion of the study.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    19 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ukraine: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    7
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 During the dose escalation portion of the study, patients were recruited at three different sites in Ukraine between February and December 2019. Due to restrictions related to the COVID 19 pandemic, recruitment for the final cohort could not be completed and a decision was made not to proceed to the randomised portion of the study.

    Pre-assignment
    Screening details
    		 ≥ 18y; histologically confirmed metastatic lung adenocarcinoma; Eastern Cooperative Oncology Group performance status 0–1; life expectancy ≥3 months; not receiving radiotherapy (except symptomatic treatment of bone metastases), targeted therapy, hormonal therapy or immunotherapy, major surgery or other study drugs within 4 weeks of study treatment

    Period 1
    Period 1 title
    Treatment Period (dose escalation) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 L-DOS47 6 μg/kg
    Arm description
    		 Patients were recruited into cohorts, minimum of three and a maximum of 6 patients per cohort.
    Arm type
    		 Experimental

    Investigational medicinal product name
    L-DOS47
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For each 21-day treatment cycle, L-DOS47 was administered by IV infusion on days 1 and 8, in combination vinorelbine (30 mg/m2) on days 1 and 8, and cisplatin (80 mg/m2) on day 1, for a total of four treatment cycles.

    Arm title
    		 L-DOS47 9 μg/kg
    Arm description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.
    Arm type
    		 Experimental

    Investigational medicinal product name
    L-DOS47
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For each 21-day treatment cycle, L-DOS47 was administered by IV infusion on days 1 and 8, in combination vinorelbine (30 mg/m2) on days 1 and 8, and cisplatin (80 mg/m2) on day 1, for a total of four treatment cycles.

    Arm title
    		 L-DOS47 12 μg/kg
    Arm description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.
    Arm type
    		 Experimental

    Investigational medicinal product name
    L-DOS47
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For each 21-day treatment cycle, L-DOS47 was administered by IV infusion on days 1 and 8, in combination vinorelbine (30 mg/m2) on days 1 and 8, and cisplatin (80 mg/m2) on day 1, for a total of four treatment cycles.

    Number of subjects in period 1
    		L-DOS47 6 μg/kg L-DOS47 9 μg/kg L-DOS47 12 μg/kg
    Started
    3
    3
    3
    Completed
    3
    3
    2
    Not completed
    0
    0
    1
         Adverse event, non-fatal
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    L-DOS47 6 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, minimum of three and a maximum of 6 patients per cohort.

    Reporting group title
    L-DOS47 9 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.

    Reporting group title
    L-DOS47 12 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.

    Reporting group values
    		 L-DOS47 6 μg/kg L-DOS47 9 μg/kg L-DOS47 12 μg/kg Total
    Number of subjects
    		 3 3 3 9
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ( 1.15 ) 59.0 ( 9.54 ) 58.7 ( 8.50 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 1 1
        Male
    		 3 3 2 8
    Race
    Units: Subjects
        caucasian
    		 3 3 3 9
    ECOG Score
    Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
    Units: Subjects
        ECOG 0
    		 0 0 1 1
        ECOG 1
    		 3 3 2 8
    Body Surface Area
    Units: m2
        arithmetic mean (standard deviation)
    		 1.78 ( 0.121 ) 1.76 ( 0.136 ) 1.83 ( 0.171 ) -
    Subject analysis sets

    Subject analysis set title
    Safety Evaluable Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Comprises all subjects who receive at least one study drug dose (partial or complete).

    Subject analysis set title
    Response Evaluable Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Consists of all subjects who enrol in the study and receive at least one dose of study drug (partial or complete) and have at least one post-baseline response assessment.

    Subject analysis sets values
    		 Safety Evaluable Group Response Evaluable Group
    Number of subjects
    9
    8
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.1 ( 6.70 )
    59.5 ( 6.89 )
    Gender categorical
    Units: Subjects
        Female
    1
    0
        Male
    8
    8
    Race
    Units: Subjects
        caucasian
    9
    8
    ECOG Score
    Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
    Units: Subjects
        ECOG 0
    1
    0
        ECOG 1
    8
    8
    Body Surface Area
    Units: m2
        arithmetic mean (standard deviation)
    1.79 ( 0.142 )
    1.80 ( 0.146 )

    End points

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    End points reporting groups
    Reporting group title
    L-DOS47 6 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, minimum of three and a maximum of 6 patients per cohort.

    Reporting group title
    L-DOS47 9 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.

    Reporting group title
    L-DOS47 12 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.

    Subject analysis set title
    Safety Evaluable Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Comprises all subjects who receive at least one study drug dose (partial or complete).

    Subject analysis set title
    Response Evaluable Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Consists of all subjects who enrol in the study and receive at least one dose of study drug (partial or complete) and have at least one post-baseline response assessment.

    Primary: Incidence drug-related adverse events as per dose-limiting toxicity definition

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    End point title
    		 Incidence drug-related adverse events as per dose-limiting toxicity definition [1]
    End point description
    Dose-limiting toxicity was defined as any NCI CTCAE v.4.0 ≥ Grade 3 non-haematologic and any ≥ Grade 4 haematologic adverse event that is at least possibly related to the study drug occurring ≤ 3 weeks after commencing L-DOS47 treatment.
    End point type
    Primary
    End point timeframe
    Observations period for dose-limiting toxicities was 21 days, the length of one complete treatment cycle.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was done, as this endpoint is simply a count for adverse events meeting definition for dose-limiting toxicity in order to establish a maximum tolerated dose (MTD).
    End point values
    		 L-DOS47 6 μg/kg L-DOS47 9 μg/kg L-DOS47 12 μg/kg Safety Evaluable Group
    Number of subjects analysed
    3
    3
    2 [2]
    8
    Units: Number of Patients
    0
    0
    0
    0
    Notes
    [2] - Third patient in cohort did not complete 21-day observation period.
    No statistical analyses for this end point

    Primary: Time to Disease Progression

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    End point title
    		 Time to Disease Progression [3]
    End point description
    Preliminary efficacy assessment of L-DOS47 in combination with cisplatin and vinorelbine.
    End point type
    Primary
    End point timeframe
    From time of first study drug administration until time of documented disease progression.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was performed, as the study was halted in the early (non-randomized) dose escalation phase with only 8 patients evaluable for time-to-disease progression.
    End point values
    		 Response Evaluable Group
    Number of subjects analysed
    8
    Units: Days
        median (full range (min-max))
    169.5 (93 to 303)
    No statistical analyses for this end point

    Secondary: Best Objective Response Rate (BORR) as per RECIST

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    End point title
    		 Best Objective Response Rate (BORR) as per RECIST
    End point description
    Best objective response rate is the sum of complete and partial responders divided by the number of patients included in the response evaluable population.
    End point type
    Secondary
    End point timeframe
    From time of first study drug administration up to 12 weeks.
    End point values
    		 L-DOS47 6 μg/kg L-DOS47 9 μg/kg L-DOS47 12 μg/kg Response Evaluable Group
    Number of subjects analysed
    3
    3
    2
    8
    Units: Number of Patients
        Complete Response
    0
    0
    0
    0
        Partial response
    1
    0
    1
    2
        Stable disease
    1
    3
    0
    4
        Progressive disease
    1
    0
    1
    2
        Objective response rate
    1
    0
    1
    2
        Clinical benefit rate
    2
    3
    1
    6
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Preliminary assessment of overall survival with L-DOS47 treatment in combination with cisplatin and vinorelbine.
    End point type
    Secondary
    End point timeframe
    From time of first study drug administration until documented death due to any cause.
    End point values
    		 Safety Evaluable Group
    Number of subjects analysed
    9
    Units: Days
        median (full range (min-max))
    275 (131 to 303)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of enrolment until 30 days after the last study drug dose.
    Adverse event reporting additional description
    Any untoward medical occurrence whether or not related to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    L-DOS47 6 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, minimum of three and a maximum of 6 patients per cohort.

    Reporting group title
    L-DOS47 9 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.

    Reporting group title
    L-DOS47 12 μg/kg
    Reporting group description
    		 Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort.

    Reporting group title
    Overall
    Reporting group description
    		 All L-DOS47 doses (6, 9, 12 μg/kg) combined.

    Serious adverse events
    		 L-DOS47 6 μg/kg L-DOS47 9 μg/kg L-DOS47 12 μg/kg Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 L-DOS47 6 μg/kg L-DOS47 9 μg/kg L-DOS47 12 μg/kg Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    9 / 9 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 9 (22.22%)
         occurrences all number
    1
    0
    1
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Body temperature increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Electrocardiogram repolarization abnormality
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Cardiac disorders
    Bundle branch block right
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    1
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    5 / 9 (55.56%)
         occurrences all number
    2
    1
    4
    7
    Leukopenia
         subjects affected / exposed
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    6 / 9 (66.67%)
         occurrences all number
    2
    4
    1
    7
    Neutropenia
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    7 / 9 (77.78%)
         occurrences all number
    3
    7
    1
    11
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Faecaloma
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Nausea
         subjects affected / exposed
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    7 / 9 (77.78%)
         occurrences all number
    5
    3
    2
    10
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 9 (22.22%)
         occurrences all number
    0
    1
    1
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    3
    0
    3
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    0
    2
    Urinary retention
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Infections and infestations
    Severe acute respiratory syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2018
    Additional text to clarify that historical biopsy samples collected at screening may be used for potential future analysis to identify the presence and density of tumour antigen and potential correlation of drug efficacy with this density. Also, remnants from centrally analysed samples may also be anonymized and pooled together for use in L-DOS47-related assay development and validation to avoid unnecessary additional blood sample collections.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Apr 2020
    Enrolment was halted due to lockdowns related to COVID pandemic.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the study being halted during the lead-in dose escalation portion of the study, only 9 patients were treated in total, instead of the additional 118 patients intended in the randomized portion of the study.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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