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NCT03576131 · OUTCOME

Volume of Distribution (Vss) at Steady State 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
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 Vss 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

Vss 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 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)5366.835.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)4788.65.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)3666.849.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)3834.634.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)4885.918.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)4127.319.2Not reportedNot reportedNot reported
Vss 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 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)4720.034.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)4287.510.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)5283.062.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)3998.124.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)4185.817.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)3427.525.1Not reportedNot reportedNot reported
Vss 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 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)4622.731.1Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)4531.96.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)3243.614.3Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)4075.326.2Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)4227.18.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)4118.5NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Vss 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 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)4722.755.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)5242.915.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)3942.463.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)3611.026.5Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)4291.69.8Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)4142.921.0Not reportedNot reportedNot reported
Vss 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 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)4899.322.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)4701.615.0Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)5177.9100.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)4054.416.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)4334.914.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)3187.841.0Not reportedNot reportedNot reported
Vss 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 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)4812.531.9Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)5077.624.1Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)3577.115.7Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)4951.242.4Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)5130.85.6Not reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)4173.9NANot 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
        35.0
        value
        5366.8
      2. group Id
        OG001
        spread
        5.0
        value
        4788.6
      3. group Id
        OG002
        spread
        49.4
        value
        3666.8
      4. group Id
        OG003
        spread
        34.3
        value
        3834.6
      5. group Id
        OG004
        spread
        18.8
        value
        4885.9
      6. group Id
        OG005
        spread
        19.2
        value
        4127.3
    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
    Vss Hx-DR5-01 Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.9
        value
        4720.0
      2. group Id
        OG001
        spread
        10.5
        value
        4287.5
      3. group Id
        OG002
        spread
        62.0
        value
        5283.0
      4. group Id
        OG003
        spread
        24.0
        value
        3998.1
      5. group Id
        OG004
        spread
        17.3
        value
        4185.8
      6. group Id
        OG005
        spread
        25.1
        value
        3427.5
    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
    Vss Hx-DR5-01 Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.1
        value
        4622.7
      2. group Id
        OG001
        spread
        6.7
        value
        4531.9
      3. group Id
        OG002
        spread
        14.3
        value
        3243.6
      4. group Id
        OG003
        spread
        26.2
        value
        4075.3
      5. group Id
        OG004
        spread
        8.7
        value
        4227.1
      6. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG005
        spread
        NA
        value
        4118.5
    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
    Vss Hx-DR5-01 Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.6
        value
        4722.7
      2. group Id
        OG001
        spread
        15.8
        value
        5242.9
      3. group Id
        OG002
        spread
        63.6
        value
        3942.4
      4. group Id
        OG003
        spread
        26.5
        value
        3611.0
      5. group Id
        OG004
        spread
        9.8
        value
        4291.6
      6. group Id
        OG005
        spread
        21.0
        value
        4142.9
    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
    Vss Hx-DR5-05 Cycle 1 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.7
        value
        4899.3
      2. group Id
        OG001
        spread
        15.0
        value
        4701.6
      3. group Id
        OG002
        spread
        100.6
        value
        5177.9
      4. group Id
        OG003
        spread
        16.4
        value
        4054.4
      5. group Id
        OG004
        spread
        14.9
        value
        4334.9
      6. group Id
        OG005
        spread
        41.0
        value
        3187.8
    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
    Vss Hx-DR5-05 Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.9
        value
        4812.5
      2. group Id
        OG001
        spread
        24.1
        value
        5077.6
      3. group Id
        OG002
        spread
        15.7
        value
        3577.1
      4. group Id
        OG003
        spread
        42.4
        value
        4951.2
      5. group Id
        OG004
        spread
        5.6
        value
        5130.8
      6. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG005
        spread
        NA
        value
        4173.9
    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
    Vss 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 Vss 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
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
type
SECONDARY
unit Of Measure
mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice