NCT04466891 · OUTCOME

Progression-free Survival (PFS) 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: 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

Group	Source count
Cohort I	80
Cohort II	7

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Cohort I	5.49	Not reported	3.65	7.29	Not reported
Cohort II	1.87	Not reported	1.22	NA	Upper Confidence Interval (CI) not estimable due to insufficient events

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
3.65
upper Limit
7.29
value
5.49
comment
Upper Confidence Interval (CI) not estimable due to insufficient events
group Id
OG001
lower Limit
1.22
upper Limit
NA
value
1.87

denoms

counts
group Id
OG000
value
80
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

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
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

Progression-free Survival (PFS) by ICR

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice