NCT04466891 · OUTCOME

Maximum Serum Concentration of ZW25

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: GEOMETRIC_MEAN
Unit: micrograms per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose

Analysis population: All subjects who received any amount of zanidatamab and have at least 1 post-baseline PK assessment were included in 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

Group	Source count
Cohort I	80
Cohort II	7

Reported measurements

Source class 1

Values in micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort I	457.6	15.44	Not reported	Not reported	Not reported
Cohort II	443.6	24.10	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
15.44
value
457.6
group Id
OG001
spread
24.10
value
443.6

denoms

counts
group Id
OG000
value
80
group Id
OG001
value
7
units
Participants

dispersion Type

Geometric Coefficient of Variation

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

GEOMETRIC_MEAN

population Description

All subjects who received any amount of zanidatamab and have at least 1 post-baseline PK assessment were included in this outcome

reporting Status

POSTED

time Frame

Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose

title

Maximum Serum Concentration of ZW25

type

SECONDARY

unit Of Measure

micrograms per milliliter

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

Preserved source evidence · Not medical advice