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NCT04466891 · FLOW

Participant flow

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers · Source last updated 2025-09-15

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

groups
  1. description
    Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+
    id
    FG000
    title
    Cohort I
  2. description
    Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.
    id
    FG001
    title
    Cohort II
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        6
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Study terminated by sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Transitioned to Named Patient Supply (NPS) program
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants must have received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for advanced disease and experienced disease progression after or developed intolerance to the most recent prior therapy.
recruitment Details
A total of 87 participants who met all eligibility criteria were enrolled and received treatment.
Complete source fields
groups
  1. description
    Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+
    id
    FG000
    title
    Cohort I
  2. description
    Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.
    id
    FG001
    title
    Cohort II
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        6
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Study terminated by sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Transitioned to Named Patient Supply (NPS) program
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants must have received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for advanced disease and experienced disease progression after or developed intolerance to the most recent prior therapy.
recruitment Details
A total of 87 participants who met all eligibility criteria were enrolled and received treatment.

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

Preserved source evidence · Not medical advice