TriangleNCT04844073 · OUTCOME
Number of Participants With Anti-drug Antibodies (ADA) in Plasma for TAK-186
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 30 days after last dose of the study drug (up to 20 months)
What was measured
The number of participants who were negative for TAK-186 ADAs at baseline and became positive in this assay, the number of participants who were negative at baseline and remained negative, and the number of participants who had positive ADAs at baseline and remained positive or became negative were reported.
Analysis population: Immunogenicity population included all 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.
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 | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 1 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 1 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 5 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 9 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 16 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 13 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 4 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 3 |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 8 |
| Cohort Expansion Phase: NSCLC | 29 |
Reported measurements
Participants Negative at Baseline for TAK-186 ADAs and Become Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 14 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 23 | Not reported | Not reported | Not reported | Not reported |
Participants Negative for TAK-186 ADAs at Baseline and Remain Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 5 | Not reported | Not reported | Not reported | Not reported |
Participants Positive for TAK-186 ADAs at Baseline and Remain Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 1 | Not reported | Not reported | Not reported | Not reported |
Participants Positive for TAK-186 ADAs at Baseline and Become Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 23
- title
- Participants Negative at Baseline for TAK-186 ADAs and Become Positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 5
- title
- Participants Negative for TAK-186 ADAs at Baseline and Remain Negative
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 1
- title
- Participants Positive for TAK-186 ADAs at Baseline and Remain Positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Participants Positive for TAK-186 ADAs at Baseline and Become Negative
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 29
- units
- Participants
- description
- The number of participants who were negative for TAK-186 ADAs at baseline and became positive in this assay, the number of participants who were negative at baseline and remained negative, and the number of participants who had positive ADAs at baseline and remained positive or became negative were reported.
- groups
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Immunogenicity population included all 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.
- reporting Status
- POSTED
- time Frame
- From start of study drug up to 30 days after last dose of the study drug (up to 20 months)
- title
- Number of Participants With Anti-drug Antibodies (ADA) in Plasma for TAK-186
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice