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NCT04844073 · OUTCOME

Tmax: Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) of TAK-186

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.

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)

What was measured

Tmax of TAK-186 was reported. As prespecified in the analysis plan, all participants in this combined cohort received the same target dose level of TAK-186. Therefore, data from these participants were pooled and analyzed as a single cohort.

Analysis population: PK population included all participants who received at least 1 dose of TAK-186 and sufficient PK data to reliably estimate 1 or more PK parameters. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific categories.

Groups in this outcome

Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone

Participants received TAK-186, Dose A 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 A is the lowest dose.

Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone

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.

Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone

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.

Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone

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.

Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone

Participants in Dose Escalation Phase and Cohort Expansion Phase 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.

Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone

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.

Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone

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 premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone10
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone61
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone12

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone10
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone61
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone12
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone3.12Not reported3.123.12Not reported
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1.92Not reported1.921.92Not reported
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone1.07Not reported1.051.13Not reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone1.08Not reported1.031.15Not reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone1.10Not reported0.927.18Not reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone1.05Not reported1.031.18Not reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone1.12Not reported1.037.00Not reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone4
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone9
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone58
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone4
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone11
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone1.05Not reported1.021.12Not reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone1.03Not reported0.601.32Not reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone1.08Not reported0.5022.80Not reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone1.10Not reported0.521.15Not reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone1.10Not reported0.521.20Not reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone0
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone56
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone4
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone10
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone1.08Not reported0.523.87Not reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone1.08Not reported0.531.17Not reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone1.13Not reported0.503.10Not reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone3
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone5
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone21
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone2
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone3
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone0.47Not reported0.470.47Not reported
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone0.58Not reported0.571.02Not reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone1.05Not reported0.602.93Not reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone1.10Not reported0.375.00Not reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone1.27Not reported1.251.28Not reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone0.78Not reported0.531.02Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.12
        upper Limit
        3.12
        value
        3.12
      2. group Id
        OG001
        lower Limit
        1.92
        upper Limit
        1.92
        value
        1.92
      3. group Id
        OG002
        lower Limit
        1.05
        upper Limit
        1.13
        value
        1.07
      4. group Id
        OG003
        lower Limit
        1.03
        upper Limit
        1.15
        value
        1.08
      5. group Id
        OG004
        lower Limit
        0.92
        upper Limit
        7.18
        value
        1.10
      6. group Id
        OG005
        lower Limit
        1.03
        upper Limit
        1.18
        value
        1.05
      7. group Id
        OG006
        lower Limit
        1.03
        upper Limit
        7.00
        value
        1.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        61
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        12
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        1.02
        upper Limit
        1.12
        value
        1.05
      2. group Id
        OG003
        lower Limit
        0.60
        upper Limit
        1.32
        value
        1.03
      3. group Id
        OG004
        lower Limit
        0.50
        upper Limit
        22.80
        value
        1.08
      4. group Id
        OG005
        lower Limit
        0.52
        upper Limit
        1.15
        value
        1.10
      5. group Id
        OG006
        lower Limit
        0.52
        upper Limit
        1.20
        value
        1.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        58
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        11
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        0.52
        upper Limit
        3.87
        value
        1.08
      2. group Id
        OG005
        lower Limit
        0.53
        upper Limit
        1.17
        value
        1.08
      3. group Id
        OG006
        lower Limit
        0.50
        upper Limit
        3.10
        value
        1.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        56
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        10
      units
      Participants
    title
    Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.47
        upper Limit
        0.47
        value
        0.47
      2. group Id
        OG002
        lower Limit
        0.57
        upper Limit
        1.02
        value
        0.58
      3. group Id
        OG003
        lower Limit
        0.60
        upper Limit
        2.93
        value
        1.05
      4. group Id
        OG004
        lower Limit
        0.37
        upper Limit
        5.00
        value
        1.10
      5. group Id
        OG005
        lower Limit
        1.25
        upper Limit
        1.28
        value
        1.27
      6. group Id
        OG006
        lower Limit
        0.53
        upper Limit
        1.02
        value
        0.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        3
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      61
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      12
    units
    Participants
description
Tmax of TAK-186 was reported. As prespecified in the analysis plan, all participants in this combined cohort received the same target dose level of TAK-186. Therefore, data from these participants were pooled and analyzed as a single cohort.
dispersion Type
Full Range
groups
  1. description
    Participants received TAK-186, Dose A 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 A is the lowest dose.
    id
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
  5. description
    Participants in Dose Escalation Phase and Cohort Expansion Phase 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
    OG004
    title
    Dose Escalation Phase and Cohort Expansion 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 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
    OG005
    title
    Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone
  7. 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 premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
    id
    OG006
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
param Type
MEDIAN
population Description
PK population included all participants who received at least 1 dose of TAK-186 and sufficient PK data to reliably estimate 1 or more PK parameters. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific categories.
reporting Status
POSTED
time Frame
Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)
title
Tmax: Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) of TAK-186
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice