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NCT04744831 · OUTCOME

Serum Concentration of Active Metabolite MAAA-1181a

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
pg/mL
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 pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3WNANANot reportedNot reportedNA - Concentrations below the lower limit of quantitation (BLQ) are set to zero for the calculation of descriptive statistics. If any concentration at a time point is BLQ, the geometric mean at that time point is not calculated and is presented as "NC", NC = NA
T-DXd 6.4 mg/kg Q3WNANANot reportedNot reportedNA - Concentrations below the lower limit of quantitation (BLQ) are set to zero for the calculation of descriptive statistics. If any concentration at a time point is BLQ, the geometric mean at that time point is not calculated and is presented as "NC", NC = NA
C1D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W80
T-DXd 6.4 mg/kg Q3W39
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W4101.4056.6Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W4313.3845.3Not reportedNot reportedNot reported
C1D1 - 5Hrs After Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W78
T-DXd 6.4 mg/kg Q3W38
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W12063.7152.8Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W15773.4439.0Not reportedNot reportedNot reported
C1D8 - 7 Days After Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W73
T-DXd 6.4 mg/kg Q3W37
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W1372.3375.8Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W1761.0267.1Not reportedNot reportedNot reported
C1D15 - 14 Days After Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W75
T-DXd 6.4 mg/kg Q3W35
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W475.3062.4Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W602.4354.1Not reportedNot reportedNot reported
C2D1 - Before Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W79
T-DXd 6.4 mg/kg Q3W35
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W209.0674.6Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W291.0755.4Not reportedNot reportedNot reported
C2D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W80
T-DXd 6.4 mg/kg Q3W36
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W1474.4871.2Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W1649.9165.8Not reportedNot reportedNot reported
C3D1 - Before Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W75
T-DXd 6.4 mg/kg Q3W33
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W279.5664.0Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W427.3389.5Not reportedNot reportedNot reported
C3D1 - End of Infusion

Analysis denominator · Participants

GroupSource count
T-DXd 5.4 mg/kg Q3W74
T-DXd 6.4 mg/kg Q3W32
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W1559.9352.6Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W1647.9253.1Not 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 pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W284.3881.4Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W494.1761.2Not 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 pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W1448.5348.5Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W1404.6754.1Not 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 pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W332.0781.3Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W578.7255.8Not 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 Q3W2
Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
T-DXd 5.4 mg/kg Q3W1182.5336.8Not reportedNot reportedNot reported
T-DXd 6.4 mg/kg Q3W1512.2532.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA - Concentrations below the lower limit of quantitation (BLQ) are set to zero for the calculation of descriptive statistics. If any concentration at a time point is BLQ, the geometric mean at that time point is not calculated and is presented as "NC", NC = NA
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        NA - Concentrations below the lower limit of quantitation (BLQ) are set to zero for the calculation of descriptive statistics. If any concentration at a time point is BLQ, the geometric mean at that time point is not calculated and is presented as "NC", NC = NA
        group Id
        OG001
        spread
        NA
        value
        NA
    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
        56.6
        value
        4101.40
      2. group Id
        OG001
        spread
        45.3
        value
        4313.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    C1D1 - End of Infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.8
        value
        12063.71
      2. group Id
        OG001
        spread
        39.0
        value
        15773.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    C1D1 - 5Hrs After Infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.8
        value
        1372.33
      2. group Id
        OG001
        spread
        67.1
        value
        1761.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    C1D8 - 7 Days After Infusion
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.4
        value
        475.30
      2. group Id
        OG001
        spread
        54.1
        value
        602.43
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    C1D15 - 14 Days After Infusion
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.6
        value
        209.06
      2. group Id
        OG001
        spread
        55.4
        value
        291.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    C2D1 - Before Infusion
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.2
        value
        1474.48
      2. group Id
        OG001
        spread
        65.8
        value
        1649.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    C2D1 - End of Infusion
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.0
        value
        279.56
      2. group Id
        OG001
        spread
        89.5
        value
        427.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    C3D1 - Before Infusion
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.6
        value
        1559.93
      2. group Id
        OG001
        spread
        53.1
        value
        1647.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    C3D1 - End of Infusion
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        81.4
        value
        284.38
      2. group Id
        OG001
        spread
        61.2
        value
        494.17
    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
        48.5
        value
        1448.53
      2. group Id
        OG001
        spread
        54.1
        value
        1404.67
    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
        81.3
        value
        332.07
      2. group Id
        OG001
        spread
        55.8
        value
        578.72
    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 Active Metabolite MAAA-1181a
type
SECONDARY
unit Of Measure
pg/mL

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

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