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NCT03576131 · OUTCOME

Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) 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
µg*h/mL
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 AUC(0-inf) 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

AUC(0-inf) 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 µg*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)39.4450.2Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)91.2066.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)85.8056.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)523.6647.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)1298.022.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)1497.758.7Not reportedNot reportedNot reported
AUC(0-inf) 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 µg*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)46.3761.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)105.3255.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)35.2430.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)530.4824.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)1071.530.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)2488.510.7Not reportedNot reportedNot reported
AUC(0-inf) 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 µg*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)37.4374.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)53.24133.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)41.4184.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)422.3226.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)1097.836.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)2653.5NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
AUC(0-inf) 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 µg*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)32.9755.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)71.2166.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)83.3751.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)508.7633.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)1052.124.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)1270.060.1Not reportedNot reportedNot reported
AUC(0-inf) 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 µg*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)39.3165.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)93.1166.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)44.76184.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)414.9024.1Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)609.9055.2Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)2273.69.0Not reportedNot reportedNot reported
AUC(0-inf) 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 µg*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)25.8757.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)51.36161.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)67.23200.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)231.4953.2Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)412.8764.1Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)2398.5NANot 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
        50.2
        value
        39.44
      2. group Id
        OG001
        spread
        66.0
        value
        91.20
      3. group Id
        OG002
        spread
        56.7
        value
        85.80
      4. group Id
        OG003
        spread
        47.5
        value
        523.66
      5. group Id
        OG004
        spread
        22.7
        value
        1298.0
      6. group Id
        OG005
        spread
        58.7
        value
        1497.7
    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
    AUC(0-inf) Hx-DR5-01 Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.5
        value
        46.37
      2. group Id
        OG001
        spread
        55.8
        value
        105.32
      3. group Id
        OG002
        spread
        30.5
        value
        35.24
      4. group Id
        OG003
        spread
        24.8
        value
        530.48
      5. group Id
        OG004
        spread
        30.7
        value
        1071.5
      6. group Id
        OG005
        spread
        10.7
        value
        2488.5
    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
    AUC(0-inf) Hx-DR5-01 Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.0
        value
        37.43
      2. group Id
        OG001
        spread
        133.3
        value
        53.24
      3. group Id
        OG002
        spread
        84.9
        value
        41.41
      4. group Id
        OG003
        spread
        26.8
        value
        422.32
      5. group Id
        OG004
        spread
        36.6
        value
        1097.8
      6. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG005
        spread
        NA
        value
        2653.5
    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
    AUC(0-inf) Hx-DR5-01 Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.4
        value
        32.97
      2. group Id
        OG001
        spread
        66.9
        value
        71.21
      3. group Id
        OG002
        spread
        51.7
        value
        83.37
      4. group Id
        OG003
        spread
        33.0
        value
        508.76
      5. group Id
        OG004
        spread
        24.7
        value
        1052.1
      6. group Id
        OG005
        spread
        60.1
        value
        1270.0
    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
    AUC(0-inf) Hx-DR5-05 Cycle 1 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.9
        value
        39.31
      2. group Id
        OG001
        spread
        66.6
        value
        93.11
      3. group Id
        OG002
        spread
        184.4
        value
        44.76
      4. group Id
        OG003
        spread
        24.1
        value
        414.90
      5. group Id
        OG004
        spread
        55.2
        value
        609.90
      6. group Id
        OG005
        spread
        9.0
        value
        2273.6
    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
    AUC(0-inf) Hx-DR5-05 Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.3
        value
        25.87
      2. group Id
        OG001
        spread
        161.6
        value
        51.36
      3. group Id
        OG002
        spread
        200.5
        value
        67.23
      4. group Id
        OG003
        spread
        53.2
        value
        231.49
      5. group Id
        OG004
        spread
        64.1
        value
        412.87
      6. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG005
        spread
        NA
        value
        2398.5
    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
    AUC(0-inf) 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 AUC(0-inf) 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
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
type
SECONDARY
unit Of Measure
µg*h/mL

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Preserved source evidence · Not medical advice