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NCT05070247 · FLOW

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A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors · Source last updated 2026-01-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received TAK-500, 8 micrograms per kilogram (µg/kg), intravenous (IV) infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
    id
    FG000
    title
    Single Agent Dose Escalation: TAK-500 8 µg/kg
  2. description
    Participants received premedication with 8 milligrams per kilogram (mg/kg) (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG001
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
  3. description
    Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG002
    title
    Single Agent Dose Escalation: TAK-500 16 µg/kg
  4. description
    Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG003
    title
    Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
  5. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG004
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
  6. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG005
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
  7. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG006
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
  8. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG007
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
  9. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG008
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
  10. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG009
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
  11. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year.
    id
    FG010
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
  12. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
    id
    FG011
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        2
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      comment
      The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.
      type
      Response-evaluable Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      12. group Id
        FG011
        num Subjects
        1
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with the specified pathologically confirmed locally advanced or metastatic solid tumors, whose disease had progressed on or is intolerant to all standard therapy were enrolled in the study. The study was terminated before initiation of Dose Expansion Phase.
recruitment Details
Participants took part in the study at sites in the United States from 14 April 2022 to 06 January 2025.
Complete source fields
groups
  1. description
    Participants received TAK-500, 8 micrograms per kilogram (µg/kg), intravenous (IV) infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
    id
    FG000
    title
    Single Agent Dose Escalation: TAK-500 8 µg/kg
  2. description
    Participants received premedication with 8 milligrams per kilogram (mg/kg) (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG001
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
  3. description
    Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG002
    title
    Single Agent Dose Escalation: TAK-500 16 µg/kg
  4. description
    Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG003
    title
    Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
  5. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
    id
    FG004
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
  6. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG005
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
  7. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG006
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
  8. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG007
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
  9. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG008
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
  10. description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
    id
    FG009
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
  11. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year.
    id
    FG010
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
  12. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
    id
    FG011
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        2
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      comment
      The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.
      type
      Response-evaluable Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      12. group Id
        FG011
        num Subjects
        1
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with the specified pathologically confirmed locally advanced or metastatic solid tumors, whose disease had progressed on or is intolerant to all standard therapy were enrolled in the study. The study was terminated before initiation of Dose Expansion Phase.
recruitment Details
Participants took part in the study at sites in the United States from 14 April 2022 to 06 January 2025.

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Preserved source evidence · Not medical advice