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NCT03653507 · BASELINE

Baseline characteristics

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW). · Source last updated 2026-07-16

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
      254
    2. group Id
      BG001
      value
      253
    3. group Id
      BG002
      value
      507
    units
    Participants
groups
  1. description
    Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
    id
    BG000
    title
    CAPOX+ Zolbetuximab
  2. description
    Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
    id
    BG001
    title
    CAPOX+ Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.1
          value
          58.6
        2. group Id
          BG001
          spread
          13
          value
          56.7
        3. group Id
          BG002
          spread
          12.6
          value
          57.6
    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
          95
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          192
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          315
        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
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          241
        3. group Id
          BG002
          value
          483
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          316
        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
          94
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          184
        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
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          157
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          315
      title
      Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          192
      title
      Non-Asia
    param Type
    NUMBER
    title
    Region (Asia vs Non-Asia)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          377
      title
      0-2 metastatic sites
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          130
      title
      >=3 metastatic sites
    param Type
    NUMBER
    title
    Number of organs with metastatic sites
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          150
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          357
      title
      No
    param Type
    NUMBER
    title
    Prior Gastrectomy
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all participants who were randomized to 1 of the treatment arms.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      254
    2. group Id
      BG001
      value
      253
    3. group Id
      BG002
      value
      507
    units
    Participants
groups
  1. description
    Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
    id
    BG000
    title
    CAPOX+ Zolbetuximab
  2. description
    Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
    id
    BG001
    title
    CAPOX+ Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.1
          value
          58.6
        2. group Id
          BG001
          spread
          13
          value
          56.7
        3. group Id
          BG002
          spread
          12.6
          value
          57.6
    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
          95
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          192
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          315
        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
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          241
        3. group Id
          BG002
          value
          483
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          316
        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
          94
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          184
        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
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          157
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          315
      title
      Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          192
      title
      Non-Asia
    param Type
    NUMBER
    title
    Region (Asia vs Non-Asia)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          377
      title
      0-2 metastatic sites
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          130
      title
      >=3 metastatic sites
    param Type
    NUMBER
    title
    Number of organs with metastatic sites
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          150
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          357
      title
      No
    param Type
    NUMBER
    title
    Prior Gastrectomy
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all participants who were randomized to 1 of the treatment arms.

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

Preserved source evidence · Not medical advice