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NCT05256381 · BASELINE

Baseline characteristics

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors · Source last updated 2025-11-17

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
      40
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      12
    5. group Id
      BG004
      value
      54
    6. group Id
      BG005
      value
      39
    7. group Id
      BG006
      value
      165
    units
    Participants
groups
  1. description
    Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
    id
    BG000
    title
    Non-small Cell Lung Cancer
  2. description
    Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
    id
    BG001
    title
    Colorectal Cancer
  3. description
    Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
    id
    BG002
    title
    Cutaneous Squamous Cell Carcinoma
  4. description
    Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
    id
    BG003
    title
    Hepatocellular Carcinoma
  5. description
    Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
    id
    BG004
    title
    Metastatic Castration-resistant Prostate Cancer
  6. description
    Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
    id
    BG005
    title
    Ovarian Cancer
  7. description
    Total of all reporting groups
    id
    BG006
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          72
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          40
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          93
        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
          spread
          10.43
          value
          63.5
        2. group Id
          BG001
          spread
          18.34
          value
          59.0
        3. group Id
          BG002
          spread
          10.95
          value
          75.5
        4. group Id
          BG003
          spread
          11.02
          value
          63.5
        5. group Id
          BG004
          spread
          6.57
          value
          68.0
        6. group Id
          BG005
          spread
          11.59
          value
          64.0
        7. group Id
          BG006
          spread
          10.90
          value
          66.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          39
        7. group Id
          BG006
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          54
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          108
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          35
        7. group Id
          BG006
          value
          140
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          36
        7. group Id
          BG006
          value
          145
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          19
      title
      Belgium
    2. 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
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
      title
      Hungary
    3. 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
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
      title
      Czechia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          8
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          56
      title
      Georgia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          21
      title
      France
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          45
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
1 patient in the Metastatic castration-resistant prostate cancer withdrew from the trial before any baseline and other data could be collected. This patient did not start any treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      12
    5. group Id
      BG004
      value
      54
    6. group Id
      BG005
      value
      39
    7. group Id
      BG006
      value
      165
    units
    Participants
groups
  1. description
    Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
    id
    BG000
    title
    Non-small Cell Lung Cancer
  2. description
    Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
    id
    BG001
    title
    Colorectal Cancer
  3. description
    Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
    id
    BG002
    title
    Cutaneous Squamous Cell Carcinoma
  4. description
    Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
    id
    BG003
    title
    Hepatocellular Carcinoma
  5. description
    Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
    id
    BG004
    title
    Metastatic Castration-resistant Prostate Cancer
  6. description
    Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
    id
    BG005
    title
    Ovarian Cancer
  7. description
    Total of all reporting groups
    id
    BG006
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          72
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          40
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          93
        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
          spread
          10.43
          value
          63.5
        2. group Id
          BG001
          spread
          18.34
          value
          59.0
        3. group Id
          BG002
          spread
          10.95
          value
          75.5
        4. group Id
          BG003
          spread
          11.02
          value
          63.5
        5. group Id
          BG004
          spread
          6.57
          value
          68.0
        6. group Id
          BG005
          spread
          11.59
          value
          64.0
        7. group Id
          BG006
          spread
          10.90
          value
          66.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          39
        7. group Id
          BG006
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          54
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          108
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          35
        7. group Id
          BG006
          value
          140
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          36
        7. group Id
          BG006
          value
          145
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          19
      title
      Belgium
    2. 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
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
      title
      Hungary
    3. 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
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
      title
      Czechia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          8
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          56
      title
      Georgia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          21
      title
      France
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          45
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
1 patient in the Metastatic castration-resistant prostate cancer withdrew from the trial before any baseline and other data could be collected. This patient did not start any treatment.

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