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NCT04383210 · BASELINE

Baseline characteristics

Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors · Source last updated 2025-04-03

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
      36
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      54
    units
    Participants
groups
  1. description
    Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
    id
    BG000
    title
    Cohort 1
  2. description
    Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
    id
    BG001
    title
    Cohort 2
  3. description
    Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
    id
    BG002
    title
    Cohort 3
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          24
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          80
          value
          61
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          84
          value
          59
        3. group Id
          BG002
          lower Limit
          57
          upper Limit
          72
          value
          66
        4. group Id
          BG003
          lower Limit
          19
          upper Limit
          84
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          20
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          39
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          47
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      36
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      54
    units
    Participants
groups
  1. description
    Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
    id
    BG000
    title
    Cohort 1
  2. description
    Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
    id
    BG001
    title
    Cohort 2
  3. description
    Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
    id
    BG002
    title
    Cohort 3
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          24
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          80
          value
          61
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          84
          value
          59
        3. group Id
          BG002
          lower Limit
          57
          upper Limit
          72
          value
          66
        4. group Id
          BG003
          lower Limit
          19
          upper Limit
          84
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          20
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          39
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          47
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice