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NCT04639219 · OUTCOME

Serum Concentrations of T-DXd and Total Anti-HER2 Antibody

A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations · Source last updated 2026-03-23

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

Measure
MEAN
Unit
microgram/milliliter (mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-infusion and 15 minutes post-infusion in Cycles 1, 2 and 4 and 5 hours post-infusion in Cycle 1 (each cycle 21 days)

What was measured

Serum samples were collected at specified timepoints to determine serum concentrations of T-DXd and total anti-HER2 antibody.

Analysis population: The Pharmacokinetic (PK) Analysis set consisted of all participants who received at least 1 dose of study treatment and had at least 1 post-dose evaluable PK data point. The population was defined by the study pharmacokineticist and the statistician prior to any PK analyses being performed. Only those participants with data available are reported.

Groups in this outcome

T-DXd

Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.

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-DXd100

Reported measurements

T-DXd: Cycle 1: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd1
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXdNANANot reportedNot reportedMean was \<lower limit of quantification (LLOQ). LLOQ was 400 nanogram (ng)/mL.
T-DXd: Cycle 1: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd96
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd116.550.8Not reportedNot reportedNot reported
T-DXd: Cycle 1: 5 hours post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd98
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd115.430.5Not reportedNot reportedNot reported
T-DXd: Cycle 2: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd91
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd11.274.1Not reportedNot reportedNot reported
T-DXd: Cycle 2: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd93
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd132.2101.5Not reportedNot reportedNot reported
T-DXd: Cycle 4: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd59
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd7.79.1Not reportedNot reportedNot reported
T-DXd: Cycle 4: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd59
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd121.740.1Not reportedNot reportedNot reported
Total anti-HER2 antibody: Cycle 1: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd9
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXdNANANot reportedNot reportedMean was \<LLOQ. LLOQ was 400 ng/mL.
Total anti-HER2 antibody: Cycle 1: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd97
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd123.852.8Not reportedNot reportedNot reported
Total anti-HER2 antibody: Cycle 1: 5 hours post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd97
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd122.142.1Not reportedNot reportedNot reported
Total anti-HER2 antibody: Cycle 2: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd88
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd6.212.4Not reportedNot reportedNot reported
Total anti-HER2 antibody: Cycle 2: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd94
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd144.4115.4Not reportedNot reportedNot reported
Total anti-HER2 antibody: Cycle 4: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd58
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd9.95.7Not reportedNot reportedNot reported
Total anti-HER2 antibody: Cycle 4: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd59
Values in microgram/milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd122.137.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Mean was \<lower limit of quantification (LLOQ). LLOQ was 400 nanogram (ng)/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    T-DXd: Cycle 1: Pre-infusion
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.8
        value
        116.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      units
      Participants
    title
    T-DXd: Cycle 1: 15 minutes post-infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.5
        value
        115.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      units
      Participants
    title
    T-DXd: Cycle 1: 5 hours post-infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.1
        value
        11.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      units
      Participants
    title
    T-DXd: Cycle 2: Pre-infusion
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        101.5
        value
        132.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        93
      units
      Participants
    title
    T-DXd: Cycle 2: 15 minutes post-infusion
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.1
        value
        7.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    T-DXd: Cycle 4: Pre-infusion
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.1
        value
        121.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    T-DXd: Cycle 4: 15 minutes post-infusion
  8. categories
    1. measurements
      1. comment
        Mean was \<LLOQ. LLOQ was 400 ng/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Total anti-HER2 antibody: Cycle 1: Pre-infusion
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.8
        value
        123.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    Total anti-HER2 antibody: Cycle 1: 15 minutes post-infusion
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.1
        value
        122.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    Total anti-HER2 antibody: Cycle 1: 5 hours post-infusion
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.4
        value
        6.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      units
      Participants
    title
    Total anti-HER2 antibody: Cycle 2: Pre-infusion
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        115.4
        value
        144.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      units
      Participants
    title
    Total anti-HER2 antibody: Cycle 2: 15 minutes post-infusion
denoms
  1. counts
    1. group Id
      OG000
      value
      100
    units
    Participants
description
Serum samples were collected at specified timepoints to determine serum concentrations of T-DXd and total anti-HER2 antibody.
dispersion Type
Standard Deviation
groups
  1. description
    Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
    id
    OG000
    title
    T-DXd
param Type
MEAN
population Description
The Pharmacokinetic (PK) Analysis set consisted of all participants who received at least 1 dose of study treatment and had at least 1 post-dose evaluable PK data point. The population was defined by the study pharmacokineticist and the statistician prior to any PK analyses being performed. Only those participants with data available are reported.
reporting Status
POSTED
time Frame
Pre-infusion and 15 minutes post-infusion in Cycles 1, 2 and 4 and 5 hours post-infusion in Cycle 1 (each cycle 21 days)
title
Serum Concentrations of T-DXd and Total Anti-HER2 Antibody
type
SECONDARY
unit Of Measure
microgram/milliliter (mL)

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Preserved source evidence · Not medical advice