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NCT04639219 · FLOW

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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.

groups
  1. description
    Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 milligram/kilogram (mg/kg) via intravenous (IV) infusion on Day 1 of each cycle (21 days), every 3 weeks until response evaluation criteria in solid tumors (RECIST) version (v) 1.1 -defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
    id
    FG000
    title
    Trastuzumab Deruxtecan (T-DXd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        55
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        102
      comment
      Participants assigned to treatment and received treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of a screening period (up to 28 days), treatment period until progressive disease (PD) and a follow-up period for participants who discontinued study treatment due to PD or other reason. A total of 102 participants received treatment in this study.
recruitment Details
This Phase II multicenter, open-label study was conducted in participants with unresectable and/or metastatic solid tumors harboring human epidermal growth factor receptor 2 (HER2) activating mutations regardless of tumor histology at 29 investigational sites in 9 countries. First participant was enrolled on 30 Dec 2020, last participant was enrolled on 24 May 2022 and data cut-off (DCO) date was 25 Jan 2023.
Complete source fields
groups
  1. description
    Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 milligram/kilogram (mg/kg) via intravenous (IV) infusion on Day 1 of each cycle (21 days), every 3 weeks until response evaluation criteria in solid tumors (RECIST) version (v) 1.1 -defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
    id
    FG000
    title
    Trastuzumab Deruxtecan (T-DXd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        55
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        102
      comment
      Participants assigned to treatment and received treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of a screening period (up to 28 days), treatment period until progressive disease (PD) and a follow-up period for participants who discontinued study treatment due to PD or other reason. A total of 102 participants received treatment in this study.
recruitment Details
This Phase II multicenter, open-label study was conducted in participants with unresectable and/or metastatic solid tumors harboring human epidermal growth factor receptor 2 (HER2) activating mutations regardless of tumor histology at 29 investigational sites in 9 countries. First participant was enrolled on 30 Dec 2020, last participant was enrolled on 24 May 2022 and data cut-off (DCO) date was 25 Jan 2023.

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Preserved source evidence · Not medical advice