Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      80

   2. group Id

      BG001

      value

      7

   3. group Id

      BG002

      value

      87

   units

   Participants

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

   BG000

   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

   BG001

   title

   Cohort II

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            9.56

            value

            62.5

         2. group Id

            BG001

            spread

            8.75

            value

            65.4

         3. group Id

            BG002

            spread

            9.48

            value

            62.7

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            45

         2. group Id

            BG001

            value

            2

         3. group Id

            BG002

            value

            47

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            35

         2. group Id

            BG001

            value

            5

         3. group Id

            BG002

            value

            40

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            6

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            72

         2. group Id

            BG001

            value

            6

         3. group Id

            BG002

            value

            78

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            3

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            3

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            1

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            52

         2. group Id

            BG001

            value

            5

         3. group Id

            BG002

            value

            57

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            23

         2. group Id

            BG001

            value

            2

         3. group Id

            BG002

            value

            25

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            4

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            4

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

population Description

The baseline demographic characteristics were assessed in the Safety Analysis Set.

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Preserved source evidence · Not medical advice