NCT04844073 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 7
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 8
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 12
- type
- Sponsor Request
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 6
- group Id
- FG004
- num Subjects
- 10
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 5
- group Id
- FG009
- num Subjects
- 12
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 10
- group Id
- FG004
- num Subjects
- 17
- group Id
- FG005
- num Subjects
- 13
- group Id
- FG006
- num Subjects
- 5
- group Id
- FG007
- num Subjects
- 4
- group Id
- FG008
- num Subjects
- 8
- group Id
- FG009
- num Subjects
- 31
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 16
- group Id
- FG005
- num Subjects
- 13
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 8
- 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
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 14
- group Id
- FG005
- num Subjects
- 11
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 2
- group Id
- FG008
- num Subjects
- 7
- 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
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 16
- group Id
- FG005
- num Subjects
- 13
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 7
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 7
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 8
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 12
- type
- Sponsor Request
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 6
- group Id
- FG004
- num Subjects
- 10
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 5
- group Id
- FG009
- num Subjects
- 12
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 10
- group Id
- FG004
- num Subjects
- 17
- group Id
- FG005
- num Subjects
- 13
- group Id
- FG006
- num Subjects
- 5
- group Id
- FG007
- num Subjects
- 4
- group Id
- FG008
- num Subjects
- 8
- group Id
- FG009
- num Subjects
- 31
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 16
- group Id
- FG005
- num Subjects
- 13
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 8
- 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
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 14
- group Id
- FG005
- num Subjects
- 11
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 2
- group Id
- FG008
- num Subjects
- 7
- 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
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 16
- group Id
- FG005
- num Subjects
- 13
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 7
- 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
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