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NCT04466891 · OUTCOME

Incidence of Anti-drug Antibodies (ADAs)

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
Up to 45 months

What was measured

Number of subjects who develop ADAs

Analysis population: All subjects who received any amount of zanidatamab and have both baseline anti-drug antibodies (ADA) and at least 1 post baseline ADA results available 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

GroupSource count
Cohort I78
Cohort II7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort I1Not reportedNot reportedNot reportedNot reported
Cohort II0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Number of subjects who develop ADAs
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
All subjects who received any amount of zanidatamab and have both baseline anti-drug antibodies (ADA) and at least 1 post baseline ADA results available were included in this outcome
reporting Status
POSTED
time Frame
Up to 45 months
title
Incidence of Anti-drug Antibodies (ADAs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice