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NCT04466891 · OUTCOME

DOR ≥ 16 Weeks by ICR

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
24 weeks, up to 45 months

What was measured

Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1

Analysis population: Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)), as evaluated by ICR, were evaluated for this outcome.

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 I33
Cohort II0

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort I28Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1
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
COUNT_OF_PARTICIPANTS
population Description
Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)), as evaluated by ICR, were evaluated for this outcome.
reporting Status
POSTED
time Frame
24 weeks, up to 45 months
title
DOR ≥ 16 Weeks by ICR
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice