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NCT04844073 · FLOW

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A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer · Source last updated 2026-09-24

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

groups
  1. description
    Participants received TAK-186, Dose A as an intravenous (IV) infusion, every week (QW) until disease progression (PD), completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
    id
    FG000
    title
    Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
  2. description
    Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
    id
    FG001
    title
    Dose Escalation Phase: TAK-186 - Dose B + Dexamethasone
  3. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
    id
    FG002
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C + Dexamethasone
  4. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
    id
    FG003
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
  5. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose E is higher than Dose C and B.
    id
    FG004
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
  6. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
    id
    FG005
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone
  7. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
    id
    FG006
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone
  8. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B and C.
    id
    FG007
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
  9. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
    id
    FG008
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone
  10. description
    Participants with non-small cell lung cancer (NSCLC) received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
    id
    FG009
    title
    Cohort Expansion Phase: NSCLC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        7
      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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        12
      type
      Sponsor Request
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        12
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        17
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        16
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        29
      comment
      Participants who received at least 1 dose of TAK-186 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment were included in the population.
      type
      Immunogenicity Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        0
      comment
      Participants who received at least 3 target doses of TAK-186 in a dose cohort, or at least 2 target doses of TAK-186, or experienced a DLT within the DLT-evaluation period were included in DLT evaluable population.
      type
      Dose Limiting Toxicity (DLT) Evaluable Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      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
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        16
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study comprised two phases: a Dose-Escalation Phase and a Cohort Expansion Phase. The dose-escalation phase was followed by a cohort-expansion phase. The study was terminated early due to the sponsor's strategic decision to discontinue the TAK-186 development program based on the limited anti-cancer activity of TAK-186 as a single agent.
recruitment Details
A total of 95 participants took part in the study from 08 March 2021 to 17 June 2025.
Complete source fields
groups
  1. description
    Participants received TAK-186, Dose A as an intravenous (IV) infusion, every week (QW) until disease progression (PD), completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
    id
    FG000
    title
    Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
  2. description
    Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
    id
    FG001
    title
    Dose Escalation Phase: TAK-186 - Dose B + Dexamethasone
  3. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
    id
    FG002
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C + Dexamethasone
  4. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
    id
    FG003
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
  5. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose E is higher than Dose C and B.
    id
    FG004
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
  6. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
    id
    FG005
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone
  7. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
    id
    FG006
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone
  8. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B and C.
    id
    FG007
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
  9. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
    id
    FG008
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone
  10. description
    Participants with non-small cell lung cancer (NSCLC) received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
    id
    FG009
    title
    Cohort Expansion Phase: NSCLC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      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
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        7
      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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        12
      type
      Sponsor Request
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        12
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        17
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        16
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        29
      comment
      Participants who received at least 1 dose of TAK-186 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment were included in the population.
      type
      Immunogenicity Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        0
      comment
      Participants who received at least 3 target doses of TAK-186 in a dose cohort, or at least 2 target doses of TAK-186, or experienced a DLT within the DLT-evaluation period were included in DLT evaluable population.
      type
      Dose Limiting Toxicity (DLT) Evaluable Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      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
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        16
      6. group Id
        FG005
        num Subjects
        13
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study comprised two phases: a Dose-Escalation Phase and a Cohort Expansion Phase. The dose-escalation phase was followed by a cohort-expansion phase. The study was terminated early due to the sponsor's strategic decision to discontinue the TAK-186 development program based on the limited anti-cancer activity of TAK-186 as a single agent.
recruitment Details
A total of 95 participants took part in the study from 08 March 2021 to 17 June 2025.

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Preserved source evidence · Not medical advice