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NCT04744831 · OUTCOME

Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer · Source last updated 2026-01-14

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

Measure
GEOMETRIC_MEAN
Unit
ug/L
Interval / dispersion
Geometric Coefficient of Variation
Time frame
C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI)

What was measured

Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022.

Analysis population: The PK Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of T-DXd and had measurable serum concentrations of T-DXd. Subjects were analyzed according to the treatment received

Groups in this outcome

T-DXd 5.4 mg/kg Q3W

Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

T-DXd 6.4 mg/kg Q3W

Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

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

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W83
T-DXd 6.4 mg/kg Q3W39

Reported measurements

C1D1 - Before Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W80
T-DXd 6.4 mg/kg Q3W39
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W5211.18388.5Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W11934.792058.9Not reportedNot reportedNot reported
C1D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W80
T-DXd 6.4 mg/kg Q3W38
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W110871.9328.8Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W121423.3720.3Not reportedNot reportedNot reported
C1D1 - 5Hrs After Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W76
T-DXd 6.4 mg/kg Q3W38
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W107339.7423.4Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W124274.0523.0Not reportedNot reportedNot reported
C1D8 - 7 Days After Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W75
T-DXd 6.4 mg/kg Q3W37
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W27646.7740.3Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W32741.7749.9Not reportedNot reportedNot reported
C1D15 - 14 Days After Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W74
T-DXd 6.4 mg/kg Q3W35
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W10920.8871.7Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W14293.1063.0Not reportedNot reportedNot reported
C2D1 - Before Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W78
T-DXd 6.4 mg/kg Q3W35
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W3723.58123.1Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W4841.90107.5Not reportedNot reportedNot reported
C2D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W78
T-DXd 6.4 mg/kg Q3W36
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W106755.2166.0Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W127427.4323.2Not reportedNot reportedNot reported
C3D1 - Before Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W75
T-DXd 6.4 mg/kg Q3W31
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W6286.0093.2Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W9100.3990.0Not reportedNot reportedNot reported
C3D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W75
T-DXd 6.4 mg/kg Q3W31
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W114763.3022.8Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W134111.3319.5Not reportedNot reportedNot reported
C4D1 - Before Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W68
T-DXd 6.4 mg/kg Q3W30
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W7388.01101.8Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W14007.9567.2Not reportedNot reportedNot reported
C4D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W67
T-DXd 6.4 mg/kg Q3W30
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W113711.0821.5Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W133956.6130.5Not reportedNot reportedNot reported
C6D1 - Before Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W59
T-DXd 6.4 mg/kg Q3W23
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W9033.0894.9Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W13535.3373.5Not reportedNot reportedNot reported
C6D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W3
T-DXd 6.4 mg/kg Q3W3
Values in ug/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W104328.7635.4Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W37091.52816.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        388.5
        value
        5211.18
      2. group Id
        OG001
        spread
        2058.9
        value
        11934.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    C1D1 - Before Infusion
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.8
        value
        110871.93
      2. group Id
        OG001
        spread
        20.3
        value
        121423.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    C1D1 - End of Infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.4
        value
        107339.74
      2. group Id
        OG001
        spread
        23.0
        value
        124274.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    C1D1 - 5Hrs After Infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.3
        value
        27646.77
      2. group Id
        OG001
        spread
        49.9
        value
        32741.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    C1D8 - 7 Days After Infusion
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.7
        value
        10920.88
      2. group Id
        OG001
        spread
        63.0
        value
        14293.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    C1D15 - 14 Days After Infusion
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        123.1
        value
        3723.58
      2. group Id
        OG001
        spread
        107.5
        value
        4841.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    C2D1 - Before Infusion
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        66.0
        value
        106755.21
      2. group Id
        OG001
        spread
        23.2
        value
        127427.43
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    C2D1 - End of Infusion
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        93.2
        value
        6286.00
      2. group Id
        OG001
        spread
        90.0
        value
        9100.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    C3D1 - Before Infusion
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.8
        value
        114763.30
      2. group Id
        OG001
        spread
        19.5
        value
        134111.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    C3D1 - End of Infusion
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        101.8
        value
        7388.01
      2. group Id
        OG001
        spread
        67.2
        value
        14007.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        30
      units
      Participants
    title
    C4D1 - Before Infusion
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.5
        value
        113711.08
      2. group Id
        OG001
        spread
        30.5
        value
        133956.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        30
      units
      Participants
    title
    C4D1 - End of Infusion
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.9
        value
        9033.08
      2. group Id
        OG001
        spread
        73.5
        value
        13535.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    C6D1 - Before Infusion
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    id
    OG000
    title
    T-DXd 5.4 mg/kg Q3W
  2. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
    id
    OG001
    title
    T-DXd 6.4 mg/kg Q3W
param Type
GEOMETRIC_MEAN
population Description
The PK Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of T-DXd and had measurable serum concentrations of T-DXd. Subjects were analyzed according to the treatment received
reporting Status
POSTED
time Frame
C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI)
title
Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody
type
SECONDARY
unit Of Measure
ug/L

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice