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NCT04844073 · OUTCOME

Number of Participants With Non-Cytokine Release Syndrome (CRS) Adverse Events (AEs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of study drug up to 90 days after last dose of the study drug (up to 22 months)

What was measured

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment.

Analysis population: Safety population included all participants who received at least 1 dose of TAK-186.

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: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone

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.

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

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.

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

Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double 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 was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.

Cohort Expansion Phase: NSCLC

Participants with 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.

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: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone17
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone13
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone4
Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone8
Cohort Expansion Phase: NSCLC31

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone5Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone10Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone17Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone13Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone5Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone4Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone8Not reportedNot reportedNot reportedNot reported
Cohort Expansion Phase: NSCLC31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
        17
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        8
      10. group Id
        OG009
        value
        31
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
      17
    6. group Id
      OG005
      value
      13
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      4
    9. group Id
      OG008
      value
      8
    10. group Id
      OG009
      value
      31
    units
    Participants
description
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment.
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 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
    OG004
    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
    OG005
    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
    OG006
    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
    OG007
    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
    OG008
    title
    Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone
  10. description
    Participants with 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
    OG009
    title
    Cohort Expansion Phase: NSCLC
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants who received at least 1 dose of TAK-186.
reporting Status
POSTED
time Frame
From start of study drug up to 90 days after last dose of the study drug (up to 22 months)
title
Number of Participants With Non-Cytokine Release Syndrome (CRS) Adverse Events (AEs)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice