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NCT03576131 · OUTCOME

Time to Reach Maximum Observed Concentration (Tmax) 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 Tmax 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

1. Biweekly Regimen (GEN1029 0.1 mg/kg)

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

2. Biweekly Regimen (GEN1029 0.2 mg/kg)

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

3. Biweekly Regimen (GEN1029 0.3 mg/kg)

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

4. Biweekly Regimen (GEN1029 1.0 mg/kg)

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

5. Biweekly Regimen (GEN1029 2.0 mg/kg)

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

6. 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
1. Biweekly Regimen (GEN1029 0.1 mg/kg)9
2. Biweekly Regimen (GEN1029 0.2 mg/kg)7
3. Biweekly Regimen (GEN1029 0.3 mg/kg)4
4. Biweekly Regimen (GEN1029 1.0 mg/kg)11
5. Biweekly Regimen (GEN1029 2.0 mg/kg)7
6. Biweekly Regimen (GEN1029 3.0 mg/kg)6

Reported measurements

Tmax Hx-DR5-01 Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
1. Biweekly Regimen (GEN1029 0.1 mg/kg)9
2. Biweekly Regimen (GEN1029 0.2 mg/kg)6
3. Biweekly Regimen (GEN1029 0.3 mg/kg)4
4. Biweekly Regimen (GEN1029 1.0 mg/kg)11
5. Biweekly Regimen (GEN1029 2.0 mg/kg)7
6. Biweekly Regimen (GEN1029 3.0 mg/kg)6
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1. Biweekly Regimen (GEN1029 0.1 mg/kg)1.58Not reported1.15.8Not reported
2. Biweekly Regimen (GEN1029 0.2 mg/kg)1.89Not reported1.45.0Not reported
3. Biweekly Regimen (GEN1029 0.3 mg/kg)1.23Not reported1.21.4Not reported
4. Biweekly Regimen (GEN1029 1.0 mg/kg)2.00Not reported0.14.7Not reported
5. Biweekly Regimen (GEN1029 2.0 mg/kg)1.30Not reported1.13.6Not reported
6. Biweekly Regimen (GEN1029 3.0 mg/kg)1.46Not reported1.03.1Not reported
Tmax Hx-DR5-01 Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
1. Biweekly Regimen (GEN1029 0.1 mg/kg)9
2. Biweekly Regimen (GEN1029 0.2 mg/kg)4
3. Biweekly Regimen (GEN1029 0.3 mg/kg)4
4. Biweekly Regimen (GEN1029 1.0 mg/kg)8
5. Biweekly Regimen (GEN1029 2.0 mg/kg)5
6. Biweekly Regimen (GEN1029 3.0 mg/kg)2
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1. Biweekly Regimen (GEN1029 0.1 mg/kg)1.25Not reported1.03.2Not reported
2. Biweekly Regimen (GEN1029 0.2 mg/kg)3.03Not reported3.05.2Not reported
3. Biweekly Regimen (GEN1029 0.3 mg/kg)1.30Not reported1.13.2Not reported
4. Biweekly Regimen (GEN1029 1.0 mg/kg)3.06Not reported1.15.1Not reported
5. Biweekly Regimen (GEN1029 2.0 mg/kg)3.25Not reported1.1163.7Not reported
6. Biweekly Regimen (GEN1029 3.0 mg/kg)1.11Not reported1.01.2Not reported
Tmax Hx-DR5-01 Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
1. Biweekly Regimen (GEN1029 0.1 mg/kg)7
2. Biweekly Regimen (GEN1029 0.2 mg/kg)4
3. Biweekly Regimen (GEN1029 0.3 mg/kg)3
4. Biweekly Regimen (GEN1029 1.0 mg/kg)6
5. Biweekly Regimen (GEN1029 2.0 mg/kg)3
6. Biweekly Regimen (GEN1029 3.0 mg/kg)1
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1. Biweekly Regimen (GEN1029 0.1 mg/kg)1.08Not reported0.03.4Not reported
2. Biweekly Regimen (GEN1029 0.2 mg/kg)1.48Not reported1.02.1Not reported
3. Biweekly Regimen (GEN1029 0.3 mg/kg)1.13Not reported1.11.3Not reported
4. Biweekly Regimen (GEN1029 1.0 mg/kg)3.08Not reported1.43.5Not reported
5. Biweekly Regimen (GEN1029 2.0 mg/kg)1.82Not reported1.13.2Not reported
6. Biweekly Regimen (GEN1029 3.0 mg/kg)3.1Not reported3.13.1Not reported
Tmax Hx-DR5-05 Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
1. Biweekly Regimen (GEN1029 0.1 mg/kg)9
2. Biweekly Regimen (GEN1029 0.2 mg/kg)6
3. Biweekly Regimen (GEN1029 0.3 mg/kg)4
4. Biweekly Regimen (GEN1029 1.0 mg/kg)11
5. Biweekly Regimen (GEN1029 2.0 mg/kg)7
6. Biweekly Regimen (GEN1029 3.0 mg/kg)6
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1. Biweekly Regimen (GEN1029 0.1 mg/kg)1.75Not reported1.15.4Not reported
2. Biweekly Regimen (GEN1029 0.2 mg/kg)2.53Not reported1.04.8Not reported
3. Biweekly Regimen (GEN1029 0.3 mg/kg)2.36Not reported1.25.5Not reported
4. Biweekly Regimen (GEN1029 1.0 mg/kg)1.60Not reported0.14.7Not reported
5. Biweekly Regimen (GEN1029 2.0 mg/kg)1.35Not reported1.13.0Not reported
6. Biweekly Regimen (GEN1029 3.0 mg/kg)1.46Not reported1.03.1Not reported
Tmax Hx-DR5-05 Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
1. Biweekly Regimen (GEN1029 0.1 mg/kg)9
2. Biweekly Regimen (GEN1029 0.2 mg/kg)4
3. Biweekly Regimen (GEN1029 0.3 mg/kg)4
4. Biweekly Regimen (GEN1029 1.0 mg/kg)8
5. Biweekly Regimen (GEN1029 2.0 mg/kg)4
6. Biweekly Regimen (GEN1029 3.0 mg/kg)2
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1. Biweekly Regimen (GEN1029 0.1 mg/kg)3.12Not reported1.15.1Not reported
2. Biweekly Regimen (GEN1029 0.2 mg/kg)2.19Not reported1.03.5Not reported
3. Biweekly Regimen (GEN1029 0.3 mg/kg)1.19Not reported1.01.4Not reported
4. Biweekly Regimen (GEN1029 1.0 mg/kg)2.26Not reported1.25.1Not reported
5. Biweekly Regimen (GEN1029 2.0 mg/kg)2.31Not reported1.13.3Not reported
6. Biweekly Regimen (GEN1029 3.0 mg/kg)2.21Not reported1.23.2Not reported
Tmax Hx-DR5-05 Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
1. Biweekly Regimen (GEN1029 0.1 mg/kg)7
2. Biweekly Regimen (GEN1029 0.2 mg/kg)4
3. Biweekly Regimen (GEN1029 0.3 mg/kg)2
4. Biweekly Regimen (GEN1029 1.0 mg/kg)6
5. Biweekly Regimen (GEN1029 2.0 mg/kg)3
6. Biweekly Regimen (GEN1029 3.0 mg/kg)1
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1. Biweekly Regimen (GEN1029 0.1 mg/kg)1.08Not reported0.01.5Not reported
2. Biweekly Regimen (GEN1029 0.2 mg/kg)1.83Not reported1.03.3Not reported
3. Biweekly Regimen (GEN1029 0.3 mg/kg)1.18Not reported1.11.3Not reported
4. Biweekly Regimen (GEN1029 1.0 mg/kg)1.42Not reported1.13.0Not reported
5. Biweekly Regimen (GEN1029 2.0 mg/kg)1.13Not reported1.01.8Not reported
6. Biweekly Regimen (GEN1029 3.0 mg/kg)3.1Not reported3.13.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        5.8
        value
        1.58
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        5.0
        value
        1.89
      3. group Id
        OG002
        lower Limit
        1.2
        upper Limit
        1.4
        value
        1.23
      4. group Id
        OG003
        lower Limit
        0.1
        upper Limit
        4.7
        value
        2.00
      5. group Id
        OG004
        lower Limit
        1.1
        upper Limit
        3.6
        value
        1.30
      6. group Id
        OG005
        lower Limit
        1.0
        upper Limit
        3.1
        value
        1.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      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
    Tmax Hx-DR5-01 Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        3.2
        value
        1.25
      2. group Id
        OG001
        lower Limit
        3.0
        upper Limit
        5.2
        value
        3.03
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        3.2
        value
        1.30
      4. group Id
        OG003
        lower Limit
        1.1
        upper Limit
        5.1
        value
        3.06
      5. group Id
        OG004
        lower Limit
        1.1
        upper Limit
        163.7
        value
        3.25
      6. group Id
        OG005
        lower Limit
        1.0
        upper Limit
        1.2
        value
        1.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    Tmax Hx-DR5-01 Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        3.4
        value
        1.08
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        2.1
        value
        1.48
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        1.3
        value
        1.13
      4. group Id
        OG003
        lower Limit
        1.4
        upper Limit
        3.5
        value
        3.08
      5. group Id
        OG004
        lower Limit
        1.1
        upper Limit
        3.2
        value
        1.82
      6. group Id
        OG005
        lower Limit
        3.1
        upper Limit
        3.1
        value
        3.1
    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
        1
      units
      Participants
    title
    Tmax Hx-DR5-01 Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        5.4
        value
        1.75
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        4.8
        value
        2.53
      3. group Id
        OG002
        lower Limit
        1.2
        upper Limit
        5.5
        value
        2.36
      4. group Id
        OG003
        lower Limit
        0.1
        upper Limit
        4.7
        value
        1.60
      5. group Id
        OG004
        lower Limit
        1.1
        upper Limit
        3.0
        value
        1.35
      6. group Id
        OG005
        lower Limit
        1.0
        upper Limit
        3.1
        value
        1.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      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
    Tmax Hx-DR5-05 Cycle 1 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        5.1
        value
        3.12
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        3.5
        value
        2.19
      3. group Id
        OG002
        lower Limit
        1.0
        upper Limit
        1.4
        value
        1.19
      4. group Id
        OG003
        lower Limit
        1.2
        upper Limit
        5.1
        value
        2.26
      5. group Id
        OG004
        lower Limit
        1.1
        upper Limit
        3.3
        value
        2.31
      6. group Id
        OG005
        lower Limit
        1.2
        upper Limit
        3.2
        value
        2.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    Tmax Hx-DR5-05 Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        1.5
        value
        1.08
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        3.3
        value
        1.83
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        1.3
        value
        1.18
      4. group Id
        OG003
        lower Limit
        1.1
        upper Limit
        3.0
        value
        1.42
      5. group Id
        OG004
        lower Limit
        1.0
        upper Limit
        1.8
        value
        1.13
      6. group Id
        OG005
        lower Limit
        3.1
        upper Limit
        3.1
        value
        3.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      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
    Tmax 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 Tmax 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
    1. 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
    2. 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
    3. 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
    4. 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
    5. 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
    6. 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
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
type
SECONDARY
unit Of Measure
h

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Preserved source evidence · Not medical advice