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    Clinical Trial Results:
    A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma

    Summary
    EudraCT number
    		 2018-002556-32
    Trial protocol
    		 DE   BE   PL   FR   CZ   HU   ES   GB   IT  
    Global end of trial date
    19 Jan 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    22 Mar 2024
    First version publication date
    01 Feb 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    ADCT-301-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04052997
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 121912
    Sponsors
    Sponsor organisation name
    ADC Therapeutics SA
    Sponsor organisation address
    Route de la Corniche, 3B, Epalinges, Switzerland, 1066
    Public contact
    Clinical Trials Information, ADC Therapeutics SA, clinicaltrials@adctherapeutics.com
    Scientific contact
    Clinical Trials Information, ADC Therapeutics SA, clinicaltrials@adctherapeutics.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
    19 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy of single agent camidanlumab tesirine in participants with relapsed or refractory Hodgkin Lymphoma.
    Protection of trial subjects
    Before initiating the study, an Investigator was required to have written and dated approval from the appropriate Institutional Review Board (IRB)/Independent Ethics Committee (IEC) for the study protocol, (i.e., a review panel responsible for ensuring the protection of the rights, safety, and well being of human participants involved in a clinical investigation, which was adequately constituted to provide assurance of that protection) according to local regulations. The IECs/IRBs were transparent in their functioning, independent of the researcher, the Sponsor, and any other undue influence, and duly qualified. All protocol amendments were reviewed and approved as required according to local regulations, prior to implementation. Other study documents subject to review during the study, including, but not limited to, serious adverse event (SAE) reports and other safety reports, were also submitted to the IEC/IRB.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    United States: 50
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 27
    Worldwide total number of subjects
    117
    EEA total number of subjects
    48
    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)
    99
    From 65 to 84 years
    17
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled from September 2019 to January 2023 across 9 countries (USA, Canada, Belgium, Czech Republic, France, Hungary, Italy, Spain, UK).

    Pre-assignment
    Screening details
    		 Participants with relapsed or refractory Hodgkin Lymphoma received intravenous (IV) infusions of camidanlumab tesirine.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Camidanlumab Tesirine
    Arm description
    		 Participants received IV infusions of camidanlumab tesirine every 3 weeks (Q3W) at a dose of 45 μg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 μg/kg for subsequent cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Camidanlumab Tesirine
    Investigational medicinal product code
    Other name
    ADCT-301
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV Infusion.

    Number of subjects in period 1
    		Camidanlumab Tesirine
    Started
    117
    Discontinued From Study
    117
    Completed
    1
    Not completed
    116
         Consent withdrawn by subject
    17
         Physician decision
    50
         Progression of Disease
    1
         Death
    43
         Lost to follow-up
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Camidanlumab Tesirine
    Reporting group description
    		 Participants received IV infusions of camidanlumab tesirine every 3 weeks (Q3W) at a dose of 45 μg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 μg/kg for subsequent cycles.

    Reporting group values
    		 Camidanlumab Tesirine Total
    Number of subjects
    		 117 117
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 99 99
        From 65-84 years
    		 17 17
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.5 ( 16.24 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 44
        Male
    		 73 73
    Ethnicity (NIH/ OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 7
        Not Hispanic or Latino
    		 104 104
        Unknown or Not Reported
    		 6 6
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 3 3
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Black or African American
    		 5 5
        White
    		 101 101
        Missing
    		 2 2
        Other
    		 5 5
    Eastern Cooperative Oncology Group (ECOG) Performance Status Score
    The ECOG Performance Status is a scale used to assess a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.
    Units: Subjects
        ECOG Score 0
    		 64 64
        ECOG Score 1
    		 47 47
        ECOG Score 2
    		 6 6
        ECOG Score 3
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Camidanlumab Tesirine
    Reporting group description
    		 Participants received IV infusions of camidanlumab tesirine every 3 weeks (Q3W) at a dose of 45 μg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 μg/kg for subsequent cycles.

    Primary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR) [1]
    End point description
    ORR according to the 2014 Lugano classification as determined by central review in all-treated participants. ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.
    End point type
    Primary
    End point timeframe
    Up to 3 years
    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 additional statistical analyses were pre-specified for this endpoint.
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Count of Participants
    82
    No statistical analyses for this end point

    Secondary: CR Rate

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    End point title
    		 CR Rate
    End point description
    CR rate defined as the number of treated participants with a best overall response (BOR) of CR. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Count of Participants
    39
    No statistical analyses for this end point

    Secondary: Relapse-Free Survival (RFS)

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    End point title
    		 Relapse-Free Survival (RFS)
    End point description
    RFS defined as the time from the documentation of CR to disease progression or death. Data from participants in the All-Treated Population who achieved CR. Values of "99999" indicate the upper confidence interval was not reached due to lack of events.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    39
    Units: Relapse-Free Survival (RFS)
        median (confidence interval 95%)
    11.07 (7.36 to 99999)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Months
        median (confidence interval 95%)
    9.13 (5.26 to 14.98)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR defined as the time from the first documentation of tumor response to disease progression or death. Data from participants in the All-Treated Population who achieved ether CR or PR by independent reviewer.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    82
    Units: Months
        median (confidence interval 95%)
    13.73 (7.85 to 14.65)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS defined as the time from first dose of study drug until death due to any cause. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety. Values of "99999" indicate median and confidence intervals were not reached due to lack of events.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Number of Participants Who Experienced At Least One Treatment-emergent Adverse Event (TEAE)

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    End point title
    		 Number of Participants Who Experienced At Least One Treatment-emergent Adverse Event (TEAE)
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Count of Participants
    116
    No statistical analyses for this end point

    Secondary: Number of Participants Who Experienced At Least One Serious Adverse Event (SAE)

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    End point title
    		 Number of Participants Who Experienced At Least One Serious Adverse Event (SAE)
    End point description
    An SAE is defined as any adverse event (AE) that: • results in death • is life threatening • requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE) • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Count of Participants
    46
    No statistical analyses for this end point

    Secondary: Number of Participants with ECOG Performance Status Score of 0-3 at the End of Trial (EOT)

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    End point title
    		 Number of Participants with ECOG Performance Status Score of 0-3 at the End of Trial (EOT)
    End point description
    The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine and reported ECOG data at EOT. This population was used in the primary analyses of efficacy and safety.
    End point type
    Secondary
    End point timeframe
    EoT (up to 3 years)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    96
    Units: Count of Participants
        Score 0
    43
        Score 1
    37
        Score 2
    12
        Score 3
    4
    No statistical analyses for this end point

    Secondary: Number of Participants Who Received Hematopoietic Stem Cell Transplant (HSCT)

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    End point title
    		 Number of Participants Who Received Hematopoietic Stem Cell Transplant (HSCT)
    End point description
    Participants receiving HSCT following camidanlumab tesirine, and without any other anticancer therapy in between, other than the therapies preparing for HSCT, were included in this analysis. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Count of Participants
    18
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    114
    Units: μg/L
    geometric mean (geometric coefficient of variation)
        Cycle 1 - Total Antibody
    825 ( 66.7 )
        Cycle 1 - Conjugated Antibody
    696 ( 66.5 )
        Cycle 1 - SG3199
    0.0170 ( 31.6 )
        Cycle 2 - Total Antibody
    797 ( 62.3 )
        Cycle 2 - Conjugated Antibody
    685 ( 61.7 )
        Cycle 2 - SG3199
    0.0180 ( 38.3 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly.
    End point type
    Secondary
    End point timeframe
    Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    114
    Units: day*ug/L
    geometric mean (geometric coefficient of variation)
        Cycle 2 - Total Antibody
    4037 ( 73.2 )
        Cycle 2 - Conjugated Antibody
    3067 ( 65.8 )
        Cycle 2 - SG3199
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    114
    Units: day*ug/L
    geometric mean (geometric coefficient of variation)
        Cycle 1 - Total Antibody
    489 ( 788 )
        Cycle 1 - Conjugated Antibody
    345 ( 607 )
        Cycle 1 - SG3199
    0 ( 104 )
        Cycle 2 - Total Antibody
    725 ( 897 )
        Cycle 2 - Conjugated Antibody
    497 ( 824 )
        Cycle 2 - SG3199
    0 ( 211 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly. Values of "99999" indicate that the geometric mean and coefficient of variation were not quantifiable due to the low level of observations.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    8
    Units: day*μg/L
    geometric mean (geometric coefficient of variation)
        Cycle 1 - Total Antibody
    6473 ( 11.9 )
        Cycle 1 - Conjugated Antibody
    5478 ( 31.2 )
        Cycle 1 - SG3199
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly. Values of "99999" indicate that the geometric mean and coefficient of variation were not quantifiable due to the low level of observations.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    8
    Units: L/day
    geometric mean (geometric coefficient of variation)
        Cycle 1 - Total antibody
    0.556 ( 47.9 )
        Cycle 1 - Conjugated Antibody
    0.733 ( 34.7 )
        Cycle 1 - SG3199
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Clearance at Steady State (CLss) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Clearance at Steady State (CLss) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly. Values of "99999" indicate that the geometric mean and coefficient of variation were not quantifiable due to the low level of observations.
    End point type
    Secondary
    End point timeframe
    Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    55
    Units: L/day
    geometric mean (geometric coefficient of variation)
        Cycle 2 - Total Antibody
    0.874 ( 75.6 )
        Cycle 2 - Conjugated Antibody
    0.958 ( 64.1 )
        Cycle 2- SG3199
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly. Values of "99999" indicate that the geometric mean and coefficient of variation were not quantifiable due to the low level of observations.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    8
    Units: day
    geometric mean (geometric coefficient of variation)
        Cycle 1 - Total Antibody
    5.91 ( 68.6 )
        Cycle 1 - Conjugated Antibody
    3.89 ( 17.5 )
        Cycle 1 - SG3199
    99999 ( 99999 )
        Cycle 2 - Total Antibody
    4.46 ( 24.6 )
        Cycle 2 - Conjugated Antibody
    4.05 ( 26.1 )
        Cycle 2 - SG3199
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Volume of Distribution at Steady State (Vss) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Volume of Distribution at Steady State (Vss) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly. Values of "99999" indicate that the geometric mean and coefficient of variation were not quantifiable due to the low level of observations.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    8
    Units: Liters
    geometric mean (geometric coefficient of variation)
        Cycle 1 - Total Antibody
    5.91 ( 68.6 )
        Cycle 1 - Conjugated Antibody
    2.81 ( 24.9 )
        Cycle 1 - SG3199
    99999 ( 99999 )
        Cycle 2 - Total Antibody
    3.14 ( 44.1 )
        Cycle 2 - Conjugated Antibody
    3.17 ( 37.6 )
        Cycle 2 - SG3199
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199

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    End point title
    		 Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
    End point description
    AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1. PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly. Values of "99999" indicate that the geometric mean and coefficient of variation were not quantifiable due to the low level of observations.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 2: day 0 to 21
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    8
    Units: Ratio
    geometric mean (geometric coefficient of variation)
        Total Antibody
    1.30 ( 52.9 )
        Conjugated Antibody
    1.04 ( 4.00 )
        SG3199
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Post Dose

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    End point title
    		 Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Post Dose
    End point description
    Detection of ADAs was performed by using a screening assay for identification of antibody positive samples/participants, a confirmation assay, and titer assessment. All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.
    End point type
    Secondary
    End point timeframe
    Up to 3 years
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    117
    Units: Count of Participants
    2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)

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    End point title
    		 Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)
    End point description
    Participants were asked to indicate their health state on a VAS with scores ranging from ‘the worst health you can imagine’ (score 0) to 'the best health you can imagine’ (score 100). Participants are asked to mark an “X” on the VAS to indicate their own health and then to report the score in a text box. Positive changes from Baseline represent an an improvement in heath. Patient Reported Outcome (PRO) Population: All participants in the all-treated patients with baseline score (at least one instrument) and at least 1 post-baseline score (in at least one instrument).
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    116
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Cycle 2 (n = 111)
    3.6 ( 14.41 )
        Cycle 3 (n = 90)
    5.2 ( 15.14 )
        Cycle 4 (n = 74)
    4.9 ( 17.65 )
        Cycle 5 (n = 62)
    4.6 ( 19.66 )
        Cycle 6 (n = 44)
    -1.2 ( 14.97 )
        Cycle 7 (n = 32)
    4.5 ( 11.88 )
        Cycle 8 (n = 19)
    4.5 ( 13.24 )
        Cycle 9 (n = 17)
    3.3 ( 13.74 )
        Cycle 10 (n = 11)
    1.3 ( 7.30 )
        Cycle 11 (n = 7)
    -0.6 ( 10.44 )
        Cycle 12 (n = 6)
    -4.8 ( 5.31 )
        Cycle 13 (n = 3)
    -1.7 ( 2.89 )
        Cycle 14 (n = 3)
    -1.7 ( 10.41 )
        Cycle 15 (n = 3)
    -3.3 ( 7.64 )
        EOT (n = 80)
    -3.1 ( 20.06 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

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    End point title
    		 Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
    End point description
    The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline. PRO Population: All participants in the all-treated patients with baseline score (at least one instrument) and at least 1 post-baseline score (in at least one instrument).
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)
    End point values
    		 Camidanlumab Tesirine
    Number of subjects analysed
    116
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Cycle 2 (n = 108)
    -0.45 ( 4.079 )
        Cycle 3 (n = 89)
    -0.02 ( 4.935 )
        Cycle 4 (n = 73)
    -0.20 ( 5.384 )
        Cycle 5 (n = 57)
    -0.13 ( 4.906 )
        Cycle 6 (n = 42)
    -1.29 ( 4.318 )
        Cycle 7 (n = 30)
    0.39 ( 3.892 )
        Cycle 8 (n = 19)
    0.40 ( 4.419 )
        Cycle 9 (n = 17)
    -1.38 ( 6.262 )
        Cycle 10 (n = 10)
    1.16 ( 2.374 )
        Cycle 11 (n = 6)
    1.50 ( 5.167 )
        Cycle 12 (n = 5)
    -1.40 ( 0.548 )
        Cycle 13 (n = 2)
    0.00 ( 0.000 )
        Cycle 14 (n = 2)
    0.00 ( 0.000 )
        Cycle 15 (n = 2)
    0.00 ( 0.000 )
        EOT (n = 77)
    -3.06 ( 6.802 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 3 years
    Adverse event reporting additional description
    All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0.
    Reporting groups
    Reporting group title
    Camidanlumab Tesirine
    Reporting group description
    		 All participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 μg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 μg/kg for subsequent cycles.

    Serious adverse events
    		 Camidanlumab Tesirine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 117 (39.32%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Superior vena cava occlusion
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 117 (2.56%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    2 / 117 (1.71%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Transplant failure
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Left ventricular failure
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Radiculopathy
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    4 / 117 (3.42%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 117 (1.71%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Parakeratosis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lichenoid keratosis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dermatosis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    3 / 117 (2.56%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Thyroiditis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 117 (1.71%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    JC virus infection
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash pustular
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Tooth infection
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 117 (1.71%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 117 (1.71%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Acidosis
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Camidanlumab Tesirine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    112 / 117 (95.73%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    9
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    34 / 117 (29.06%)
         occurrences all number
    47
    Oedema peripheral
         subjects affected / exposed
    14 / 117 (11.97%)
         occurrences all number
    15
    Face oedema
         subjects affected / exposed
    7 / 117 (5.98%)
         occurrences all number
    7
    Chills
         subjects affected / exposed
    12 / 117 (10.26%)
         occurrences all number
    14
    Asthenia
         subjects affected / exposed
    8 / 117 (6.84%)
         occurrences all number
    8
    Fatigue
         subjects affected / exposed
    45 / 117 (38.46%)
         occurrences all number
    53
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    10 / 117 (8.55%)
         occurrences all number
    11
    Dyspnoea
         subjects affected / exposed
    16 / 117 (13.68%)
         occurrences all number
    18
    Cough
         subjects affected / exposed
    12 / 117 (10.26%)
         occurrences all number
    12
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    16 / 117 (13.68%)
         occurrences all number
    17
    Anxiety
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    8
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    15 / 117 (12.82%)
         occurrences all number
    16
    Amylase increased
         subjects affected / exposed
    9 / 117 (7.69%)
         occurrences all number
    12
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    20 / 117 (17.09%)
         occurrences all number
    26
    Aspartate aminotransferase increased
         subjects affected / exposed
    14 / 117 (11.97%)
         occurrences all number
    17
    Blood alkaline phosphatase increased
         subjects affected / exposed
    11 / 117 (9.40%)
         occurrences all number
    15
    Lipase increased
         subjects affected / exposed
    9 / 117 (7.69%)
         occurrences all number
    11
    Weight decreased
         subjects affected / exposed
    9 / 117 (7.69%)
         occurrences all number
    9
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    8 / 117 (6.84%)
         occurrences all number
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 117 (16.24%)
         occurrences all number
    22
    Dysgeusia
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    6
    Dizziness
         subjects affected / exposed
    12 / 117 (10.26%)
         occurrences all number
    13
    Neuropathy peripheral
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    6
    Peripheral sensory neuropathy
         subjects affected / exposed
    7 / 117 (5.98%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    18 / 117 (15.38%)
         occurrences all number
    26
    Neutropenia
         subjects affected / exposed
    19 / 117 (16.24%)
         occurrences all number
    29
    Thrombocytopenia
         subjects affected / exposed
    24 / 117 (20.51%)
         occurrences all number
    34
    Anaemia
         subjects affected / exposed
    29 / 117 (24.79%)
         occurrences all number
    39
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    19 / 117 (16.24%)
         occurrences all number
    26
    Dry mouth
         subjects affected / exposed
    7 / 117 (5.98%)
         occurrences all number
    7
    Stomatitis
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    32 / 117 (27.35%)
         occurrences all number
    40
    Dyspepsia
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    6
    Constipation
         subjects affected / exposed
    20 / 117 (17.09%)
         occurrences all number
    23
    Abdominal pain
         subjects affected / exposed
    12 / 117 (10.26%)
         occurrences all number
    14
    Vomiting
         subjects affected / exposed
    13 / 117 (11.11%)
         occurrences all number
    17
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    31 / 117 (26.50%)
         occurrences all number
    36
    Rash maculo-papular
         subjects affected / exposed
    38 / 117 (32.48%)
         occurrences all number
    46
    Erythema
         subjects affected / exposed
    14 / 117 (11.97%)
         occurrences all number
    19
    Dry skin
         subjects affected / exposed
    7 / 117 (5.98%)
         occurrences all number
    8
    Pruritus
         subjects affected / exposed
    28 / 117 (23.93%)
         occurrences all number
    30
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    8 / 117 (6.84%)
         occurrences all number
    8
    Hypothyroidism
         subjects affected / exposed
    12 / 117 (10.26%)
         occurrences all number
    12
    Thyroiditis
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    19 / 117 (16.24%)
         occurrences all number
    22
    Pain in extremity
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    9
    Myalgia
         subjects affected / exposed
    11 / 117 (9.40%)
         occurrences all number
    15
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 117 (5.98%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    14 / 117 (11.97%)
         occurrences all number
    21
    Dehydration
         subjects affected / exposed
    6 / 117 (5.13%)
         occurrences all number
    7
    Decreased appetite
         subjects affected / exposed
    12 / 117 (10.26%)
         occurrences all number
    12
    Hypokalaemia
         subjects affected / exposed
    14 / 117 (11.97%)
         occurrences all number
    18
    Hypomagnesaemia
         subjects affected / exposed
    9 / 117 (7.69%)
         occurrences all number
    10
    Hyponatraemia
         subjects affected / exposed
    7 / 117 (5.98%)
         occurrences all number
    9
    Hypophosphataemia
         subjects affected / exposed
    21 / 117 (17.95%)
         occurrences all number
    29

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2019
    The primary reason for Protocol Amendment 1 was to include changes based on recommendations by the United States (US) Food and Drug Administration (FDA). In addition, substantial updates in line with study needs had been introduced, e.g., revision of study drug instructions or clarifications of male participant contraception methods.
    24 Apr 2020
    The primary reason for this global Protocol Amendment 2 was to combine the updates required by the Regulatory Authorities and IRB/IEC received to date in one global protocol version. In addition, updates in line with study needs had been introduced, such as the inclusion of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) added to the list of pathogens associated to Guillain-Barré syndrome (GBS), additional recommendation to capture early signs of polyradiculopathy/GBS, and the update of the study stopping rule.
    01 Jul 2020
    The primary reason for this global Protocol Amendment 3 was to update the stopping rule and to exclude participants that are tested positive for influenza and SARS-CoV-2 before initiating study treatment, based on the recommendations by the FDA.
    06 Nov 2020
    The primary reasons for this global Protocol Amendment 4 were to implement the recommendations from the independent Data and Safety Monitoring Board (iDSMB), including the addition of varicella zoster virus prophylaxis, an update of the management guidance in respect to specific autoimmune toxicities, and to address the requests from the French and Belgian regulatory authorities.
    16 Feb 2022
    The primary reason for Protocol Amendment 5 is to extend the contraception period after last dose of camidanlumab tesirine, following an urgent safety measure. The contraception period is determined based on the compound properties and half-life, and has been updated due to a recently revised half-life value of camidanlumab tesirine.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    17 Apr 2020
    The US FDA placed the trial ADCT-301-201 on a partial clinical hold following 2 cases of GBS/polyradiculopathy. An ad hoc iDSMB meeting to perform comprehensive safety evaluation was held on 15 Apr 2020 (recommendations issued: accrual can continue; create a stopping rule that rules out a probability of ≥ 20% of GBS). ADCT applied the conditions set out by the US FDA in the partial clinical hold to all investigator sites. Under the partial clinical hold, no new participants were treated with camidanlumab tesirine. All ongoing participants at the time of the clinical hold were informed and consented to continue, with the following specifications: Ongoing participants who were deriving clinical benefit (includes participants with an objective response and stable disease) were permitted to continue treatment per protocol if they chose after being re-consented. In the EU, all countries were notified about the clinical hold in mid Apr 2020. The clinical hold was subsequently lifted in the EU countries in Aug-Oct 2020.
    02 Jul 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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