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NCT03576131 · OUTCOME

Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05

GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors · Source last updated 2023-08-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
mL/h
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

What was measured

The CL of Hx-DR5-01 and Hx-DR5-05 are reported.

Analysis population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.

Groups in this outcome

Biweekly Regimen (GEN1029 0.1 mg/kg)

Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.

Biweekly Regimen (GEN1029 0.2 mg/kg)

Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 0.3 mg/kg)

Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 1.0 mg/kg)

Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 2.0 mg/kg)

Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 3.0 mg/kg)

Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)9
Biweekly Regimen (GEN1029 0.2 mg/kg)7
Biweekly Regimen (GEN1029 0.3 mg/kg)4
Biweekly Regimen (GEN1029 1.0 mg/kg)11
Biweekly Regimen (GEN1029 2.0 mg/kg)7
Biweekly Regimen (GEN1029 3.0 mg/kg)6

Reported measurements

CL Hx-DR5-01 Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)8
Biweekly Regimen (GEN1029 0.2 mg/kg)6
Biweekly Regimen (GEN1029 0.3 mg/kg)4
Biweekly Regimen (GEN1029 1.0 mg/kg)11
Biweekly Regimen (GEN1029 2.0 mg/kg)7
Biweekly Regimen (GEN1029 3.0 mg/kg)6
Values in mL/h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)95.9853.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)91.2751.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)123.7569.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)65.3656.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)59.0731.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)69.5051.0Not reportedNot reportedNot reported
CL Hx-DR5-01 Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)8
Biweekly Regimen (GEN1029 0.2 mg/kg)4
Biweekly Regimen (GEN1029 0.3 mg/kg)4
Biweekly Regimen (GEN1029 1.0 mg/kg)7
Biweekly Regimen (GEN1029 2.0 mg/kg)4
Biweekly Regimen (GEN1029 3.0 mg/kg)2
Values in mL/h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)77.3670.2Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)79.9751.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)155.7672.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)58.0731.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)73.4328.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)36.922.0Not reportedNot reportedNot reported
CL Hx-DR5-01 Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)6
Biweekly Regimen (GEN1029 0.2 mg/kg)4
Biweekly Regimen (GEN1029 0.3 mg/kg)2
Biweekly Regimen (GEN1029 1.0 mg/kg)6
Biweekly Regimen (GEN1029 2.0 mg/kg)3
Biweekly Regimen (GEN1029 3.0 mg/kg)1
Values in mL/h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)99.5357.1Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)131.4676.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)111.3312.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)62.9042.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)62.6426.1Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)37.87NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
CL Hx-DR5-05 Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)8
Biweekly Regimen (GEN1029 0.2 mg/kg)6
Biweekly Regimen (GEN1029 0.3 mg/kg)4
Biweekly Regimen (GEN1029 1.0 mg/kg)11
Biweekly Regimen (GEN1029 2.0 mg/kg)6
Biweekly Regimen (GEN1029 3.0 mg/kg)6
Values in mL/h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)111.1062.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)116.8951.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)127.3569.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)67.2837.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)69.3929.2Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)81.9653.9Not reportedNot reportedNot reported
CL Hx-DR5-05 Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)7
Biweekly Regimen (GEN1029 0.2 mg/kg)4
Biweekly Regimen (GEN1029 0.3 mg/kg)3
Biweekly Regimen (GEN1029 1.0 mg/kg)6
Biweekly Regimen (GEN1029 2.0 mg/kg)3
Biweekly Regimen (GEN1029 3.0 mg/kg)2
Values in mL/h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)90.1869.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)90.4567.1Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)131.51240.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)79.7228.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)134.1151.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)40.413.7Not reportedNot reportedNot reported
CL Hx-DR5-05 Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)5
Biweekly Regimen (GEN1029 0.2 mg/kg)3
Biweekly Regimen (GEN1029 0.3 mg/kg)2
Biweekly Regimen (GEN1029 1.0 mg/kg)6
Biweekly Regimen (GEN1029 2.0 mg/kg)2
Biweekly Regimen (GEN1029 3.0 mg/kg)1
Values in mL/h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)143.0950.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)140.3877.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)68.5742.2Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)114.7459.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)172.6678.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)41.90NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.8
        value
        95.98
      2. group Id
        OG001
        spread
        51.4
        value
        91.27
      3. group Id
        OG002
        spread
        69.9
        value
        123.75
      4. group Id
        OG003
        spread
        56.5
        value
        65.36
      5. group Id
        OG004
        spread
        31.4
        value
        59.07
      6. group Id
        OG005
        spread
        51.0
        value
        69.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        6
      units
      Participants
    title
    CL Hx-DR5-01 Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.2
        value
        77.36
      2. group Id
        OG001
        spread
        51.8
        value
        79.97
      3. group Id
        OG002
        spread
        72.6
        value
        155.76
      4. group Id
        OG003
        spread
        31.8
        value
        58.07
      5. group Id
        OG004
        spread
        28.0
        value
        73.43
      6. group Id
        OG005
        spread
        2.0
        value
        36.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    CL Hx-DR5-01 Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.1
        value
        99.53
      2. group Id
        OG001
        spread
        76.0
        value
        131.46
      3. group Id
        OG002
        spread
        12.9
        value
        111.33
      4. group Id
        OG003
        spread
        42.5
        value
        62.90
      5. group Id
        OG004
        spread
        26.1
        value
        62.64
      6. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG005
        spread
        NA
        value
        37.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
      units
      Participants
    title
    CL Hx-DR5-01 Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.5
        value
        111.10
      2. group Id
        OG001
        spread
        51.3
        value
        116.89
      3. group Id
        OG002
        spread
        69.3
        value
        127.35
      4. group Id
        OG003
        spread
        37.4
        value
        67.28
      5. group Id
        OG004
        spread
        29.2
        value
        69.39
      6. group Id
        OG005
        spread
        53.9
        value
        81.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        6
      units
      Participants
    title
    CL Hx-DR5-05 Cycle 1 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        69.4
        value
        90.18
      2. group Id
        OG001
        spread
        67.1
        value
        90.45
      3. group Id
        OG002
        spread
        240.7
        value
        131.51
      4. group Id
        OG003
        spread
        28.8
        value
        79.72
      5. group Id
        OG004
        spread
        51.9
        value
        134.11
      6. group Id
        OG005
        spread
        3.7
        value
        40.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    CL Hx-DR5-05 Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.5
        value
        143.09
      2. group Id
        OG001
        spread
        77.3
        value
        140.38
      3. group Id
        OG002
        spread
        42.2
        value
        68.57
      4. group Id
        OG003
        spread
        59.8
        value
        114.74
      5. group Id
        OG004
        spread
        78.9
        value
        172.66
      6. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG005
        spread
        NA
        value
        41.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        1
      units
      Participants
    title
    CL Hx-DR5-05 Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      6
    units
    Participants
description
The CL of Hx-DR5-01 and Hx-DR5-05 are reported.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
    id
    OG000
    title
    Biweekly Regimen (GEN1029 0.1 mg/kg)
  2. description
    Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG001
    title
    Biweekly Regimen (GEN1029 0.2 mg/kg)
  3. description
    Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG002
    title
    Biweekly Regimen (GEN1029 0.3 mg/kg)
  4. description
    Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG003
    title
    Biweekly Regimen (GEN1029 1.0 mg/kg)
  5. description
    Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG004
    title
    Biweekly Regimen (GEN1029 2.0 mg/kg)
  6. description
    Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG005
    title
    Biweekly Regimen (GEN1029 3.0 mg/kg)
param Type
GEOMETRIC_MEAN
population Description
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
reporting Status
POSTED
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
title
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
type
SECONDARY
unit Of Measure
mL/h

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Preserved source evidence · Not medical advice