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NCT04844073 · OUTCOME

Vss: Volume of Distribution at Steady State for 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
MEAN
Unit
liters (L)
Interval / dispersion
Standard Deviation
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

Vss 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. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure \& "number analyzed" signifies participants at specific categories. No participants in Dose Escalation Phase: TAK-186 - Dose A Arm group attended for Vss. TAK-186 was administered QW and had a LiD regimen including 1-step and 2-step lead-in. Analysis at the lead-in dose time points was not possible due to insufficient data points.

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 + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1
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 + 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

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1
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 + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone0
Values in liters (L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone19400NANot reportedNot reportedThe standard deviation was not estimable for a single participant.
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 + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone0
Values in liters (L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone226004620Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone244008170Not reportedNot reportedNot 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 liters (L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone2170012700Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone139003420Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone223009030Not reportedNot reportedNot reported
Cycle 2 Day 1

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 + 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 + Dexamethasone1
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone3
Values in liters (L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone1810017400Not reportedNot reportedNot reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone1520011300Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone35500NANot reportedNot reportedThe standard deviation was not estimable for a single participant.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone10900001490000Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The standard deviation was not estimable for a single participant.
        group Id
        OG001
        spread
        NA
        value
        19400
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG002
        spread
        4620
        value
        22600
      2. group Id
        OG003
        spread
        8170
        value
        24400
    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
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG004
        spread
        12700
        value
        21700
      2. group Id
        OG005
        spread
        3420
        value
        13900
      3. group Id
        OG006
        spread
        9030
        value
        22300
    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
        OG003
        spread
        17400
        value
        18100
      2. group Id
        OG004
        spread
        11300
        value
        15200
      3. comment
        The standard deviation was not estimable for a single participant.
        group Id
        OG005
        spread
        NA
        value
        35500
      4. group Id
        OG006
        spread
        1490000
        value
        1090000
    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
        5
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        3
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      56
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      10
    units
    Participants
description
Vss 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
Standard Deviation
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
MEAN
population Description
PK population. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure \& "number analyzed" signifies participants at specific categories. No participants in Dose Escalation Phase: TAK-186 - Dose A Arm group attended for Vss. TAK-186 was administered QW and had a LiD regimen including 1-step and 2-step lead-in. Analysis at the lead-in dose time points was not possible due to insufficient data points.
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
Vss: Volume of Distribution at Steady State for TAK-186
type
SECONDARY
unit Of Measure
liters (L)

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Preserved source evidence · Not medical advice