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NCT04639219 · OUTCOME

Serum Concentrations of Deruxtecan (MAAA-1181a)

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
ng/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 MAAA-1181a.

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

MAAA-1181a: Cycle 1: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd0
MAAA-1181a: Cycle 1: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd99
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd4.72.9Not reportedNot reportedNot reported
MAAA-1181a: Cycle 1: 5 hours post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd95
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd10.55.1Not reportedNot reportedNot reported
MAAA-1181a: Cycle 2: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd90
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd0.20.1Not reportedNot reportedNot reported
MAAA-1181a: Cycle 2: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd94
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd2.21.5Not reportedNot reportedNot reported
MAAA-1181a: Cycle 4: Pre-infusion

Analysis denominator · Participants

GroupSource count
T-DXd57
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd0.30.2Not reportedNot reportedNot reported
MAAA-1181a: Cycle 4: 15 minutes post-infusion

Analysis denominator · Participants

GroupSource count
T-DXd58
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
T-DXd1.50.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    MAAA-1181a: Cycle 1: Pre-infusion
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.9
        value
        4.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        99
      units
      Participants
    title
    MAAA-1181a: Cycle 1: 15 minutes post-infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.1
        value
        10.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      units
      Participants
    title
    MAAA-1181a: Cycle 1: 5 hours post-infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1
        value
        0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      units
      Participants
    title
    MAAA-1181a: Cycle 2: Pre-infusion
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5
        value
        2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      units
      Participants
    title
    MAAA-1181a: Cycle 2: 15 minutes post-infusion
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    MAAA-1181a: Cycle 4: Pre-infusion
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    MAAA-1181a: Cycle 4: 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 MAAA-1181a.
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 Deruxtecan (MAAA-1181a)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice