Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03576131 · OUTCOME

Half-life Lambda-z (t1/2) 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
MEDIAN
Unit
h
Interval / dispersion
Full Range
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 t1/2 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

T1/2 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)41.69Not reported20.761.1Not reported
Biweekly Regimen (GEN1029 0.2 mg/kg)41.31Not reported16.660.3Not reported
Biweekly Regimen (GEN1029 0.3 mg/kg)18.10Not reported11.440.5Not reported
Biweekly Regimen (GEN1029 1.0 mg/kg)40.27Not reported5.166.8Not reported
Biweekly Regimen (GEN1029 2.0 mg/kg)70.90Not reported50.586.2Not reported
Biweekly Regimen (GEN1029 3.0 mg/kg)42.45Not reported17.980.5Not reported
T1/2 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)37.75Not reported29.172.3Not reported
Biweekly Regimen (GEN1029 0.2 mg/kg)39.57Not reported21.762.5Not reported
Biweekly Regimen (GEN1029 0.3 mg/kg)24.47Not reported16.929.7Not reported
Biweekly Regimen (GEN1029 1.0 mg/kg)49.64Not reported36.271.5Not reported
Biweekly Regimen (GEN1029 2.0 mg/kg)33.62Not reported29.088.2Not reported
Biweekly Regimen (GEN1029 3.0 mg/kg)65.85Not reported54.677.1Not reported
T1/2 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)27.64Not reported16.284.1Not reported
Biweekly Regimen (GEN1029 0.2 mg/kg)19.93Not reported13.166.9Not reported
Biweekly Regimen (GEN1029 0.3 mg/kg)20.16Not reported16.224.1Not reported
Biweekly Regimen (GEN1029 1.0 mg/kg)47.86Not reported30.860.0Not reported
Biweekly Regimen (GEN1029 2.0 mg/kg)44.51Not reported40.164.0Not reported
Biweekly Regimen (GEN1029 3.0 mg/kg)77.00Not reported77.0077.00Not reported
T1/2 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)35.55Not reported12.546.5Not reported
Biweekly Regimen (GEN1029 0.2 mg/kg)34.50Not reported15.652.5Not reported
Biweekly Regimen (GEN1029 0.3 mg/kg)19.10Not reported14.644.0Not reported
Biweekly Regimen (GEN1029 1.0 mg/kg)36.33Not reported26.470.6Not reported
Biweekly Regimen (GEN1029 2.0 mg/kg)42.68Not reported35.368.8Not reported
Biweekly Regimen (GEN1029 3.0 mg/kg)37.71Not reported16.669.6Not reported
T1/2 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)32.46Not reported19.371.4Not reported
Biweekly Regimen (GEN1029 0.2 mg/kg)37.71Not reported17.380.7Not reported
Biweekly Regimen (GEN1029 0.3 mg/kg)25.43Not reported13.962.3Not reported
Biweekly Regimen (GEN1029 1.0 mg/kg)37.69Not reported28.443.5Not reported
Biweekly Regimen (GEN1029 2.0 mg/kg)26.68Not reported13.129.4Not reported
Biweekly Regimen (GEN1029 3.0 mg/kg)51.97Not reported30.873.1Not reported
T1/2 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)25.30Not reported12.039.6Not reported
Biweekly Regimen (GEN1029 0.2 mg/kg)18.75Not reported15.457.4Not reported
Biweekly Regimen (GEN1029 0.3 mg/kg)41.26Not reported24.358.2Not reported
Biweekly Regimen (GEN1029 1.0 mg/kg)33.90Not reported14.262.1Not reported
Biweekly Regimen (GEN1029 2.0 mg/kg)22.83Not reported13.232.5Not reported
Biweekly Regimen (GEN1029 3.0 mg/kg)70.9Not reported70.970.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.7
        upper Limit
        61.1
        value
        41.69
      2. group Id
        OG001
        lower Limit
        16.6
        upper Limit
        60.3
        value
        41.31
      3. group Id
        OG002
        lower Limit
        11.4
        upper Limit
        40.5
        value
        18.10
      4. group Id
        OG003
        lower Limit
        5.1
        upper Limit
        66.8
        value
        40.27
      5. group Id
        OG004
        lower Limit
        50.5
        upper Limit
        86.2
        value
        70.90
      6. group Id
        OG005
        lower Limit
        17.9
        upper Limit
        80.5
        value
        42.45
    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
    T1/2 Hx-DR5-01 Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.1
        upper Limit
        72.3
        value
        37.75
      2. group Id
        OG001
        lower Limit
        21.7
        upper Limit
        62.5
        value
        39.57
      3. group Id
        OG002
        lower Limit
        16.9
        upper Limit
        29.7
        value
        24.47
      4. group Id
        OG003
        lower Limit
        36.2
        upper Limit
        71.5
        value
        49.64
      5. group Id
        OG004
        lower Limit
        29.0
        upper Limit
        88.2
        value
        33.62
      6. group Id
        OG005
        lower Limit
        54.6
        upper Limit
        77.1
        value
        65.85
    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
    T1/2 Hx-DR5-01 Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.2
        upper Limit
        84.1
        value
        27.64
      2. group Id
        OG001
        lower Limit
        13.1
        upper Limit
        66.9
        value
        19.93
      3. group Id
        OG002
        lower Limit
        16.2
        upper Limit
        24.1
        value
        20.16
      4. group Id
        OG003
        lower Limit
        30.8
        upper Limit
        60.0
        value
        47.86
      5. group Id
        OG004
        lower Limit
        40.1
        upper Limit
        64.0
        value
        44.51
      6. group Id
        OG005
        lower Limit
        77.00
        upper Limit
        77.00
        value
        77.00
    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
    T1/2 Hx-DR5-01 Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.5
        upper Limit
        46.5
        value
        35.55
      2. group Id
        OG001
        lower Limit
        15.6
        upper Limit
        52.5
        value
        34.50
      3. group Id
        OG002
        lower Limit
        14.6
        upper Limit
        44.0
        value
        19.10
      4. group Id
        OG003
        lower Limit
        26.4
        upper Limit
        70.6
        value
        36.33
      5. group Id
        OG004
        lower Limit
        35.3
        upper Limit
        68.8
        value
        42.68
      6. group Id
        OG005
        lower Limit
        16.6
        upper Limit
        69.6
        value
        37.71
    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
    T1/2 Hx-DR5-05 Cycle 1 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.3
        upper Limit
        71.4
        value
        32.46
      2. group Id
        OG001
        lower Limit
        17.3
        upper Limit
        80.7
        value
        37.71
      3. group Id
        OG002
        lower Limit
        13.9
        upper Limit
        62.3
        value
        25.43
      4. group Id
        OG003
        lower Limit
        28.4
        upper Limit
        43.5
        value
        37.69
      5. group Id
        OG004
        lower Limit
        13.1
        upper Limit
        29.4
        value
        26.68
      6. group Id
        OG005
        lower Limit
        30.8
        upper Limit
        73.1
        value
        51.97
    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
    T1/2 Hx-DR5-05 Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.0
        upper Limit
        39.6
        value
        25.30
      2. group Id
        OG001
        lower Limit
        15.4
        upper Limit
        57.4
        value
        18.75
      3. group Id
        OG002
        lower Limit
        24.3
        upper Limit
        58.2
        value
        41.26
      4. group Id
        OG003
        lower Limit
        14.2
        upper Limit
        62.1
        value
        33.90
      5. group Id
        OG004
        lower Limit
        13.2
        upper Limit
        32.5
        value
        22.83
      6. group Id
        OG005
        lower Limit
        70.9
        upper Limit
        70.9
        value
        70.9
    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
    T1/2 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 t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.
dispersion Type
Full Range
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
MEDIAN
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
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
type
SECONDARY
unit Of Measure
h

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

Preserved source evidence · Not medical advice