Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04466891 · OUTCOME

PFS by Investigator Assessment

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 45 months

What was measured

The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause

Groups in this outcome

Cohort I

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+

Cohort II

Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort I80
Cohort II7

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort I5.37Not reported3.557.29Not reported
Cohort II1.77Not reported0.791.94Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.55
        upper Limit
        7.29
        value
        5.37
      2. group Id
        OG001
        lower Limit
        0.79
        upper Limit
        1.94
        value
        1.77
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    2. group Id
      OG001
      value
      7
    units
    Participants
description
The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Cohort II
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 45 months
title
PFS by Investigator Assessment
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice