TriangleNCT01871727 · OUTCOME
Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
What was measured
Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported.
Analysis population: Lead-in PK Analysis Set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained.
Groups in this outcome
Lead-In Part: E7777 6 mcg/kg
Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 9 mcg/kg
Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
Lead-In Part: E7777 12 mcg/kg
Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 15 mcg/kg
Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
| Group | Source count |
|---|---|
| Lead-In Part: E7777 6 mcg/kg | 2 |
| Lead-In Part: E7777 9 mcg/kg | 8 |
| Lead-In Part: E7777 12 mcg/kg | 9 |
| Lead-In Part: E7777 15 mcg/kg | 2 |
Reported measurements
Cycle 1 Day 1 (Anti-E7777 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 88.9 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
Cycle 2 Day 1 (Anti-E7777 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Cycle 3 Day 1 (Anti-E7777 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Cycle 5 Day 1 (Anti-E7777 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Cycle 1 Day 1 (Anti-IL-2 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 37.5 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Cycle 2 Day 1 (Anti-IL-2 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 87.5 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Cycle 3 Day 1 (Anti-IL-2 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Cycle 5 Day 1 (Anti-IL-2 Antibodies)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 50.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 88.9
- group Id
- OG003
- value
- 100.0
- title
- Cycle 1 Day 1 (Anti-E7777 Antibodies)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 83.3
- group Id
- OG003
- value
- 0
- title
- Cycle 2 Day 1 (Anti-E7777 Antibodies)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 0
- title
- Cycle 3 Day 1 (Anti-E7777 Antibodies)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 0
- title
- Cycle 5 Day 1 (Anti-E7777 Antibodies)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 37.5
- group Id
- OG002
- value
- 33.3
- group Id
- OG003
- value
- 0
- title
- Cycle 1 Day 1 (Anti-IL-2 Antibodies)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 87.5
- group Id
- OG002
- value
- 83.3
- group Id
- OG003
- value
- 0
- title
- Cycle 2 Day 1 (Anti-IL-2 Antibodies)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 0
- title
- Cycle 3 Day 1 (Anti-IL-2 Antibodies)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 83.3
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 0
- title
- Cycle 5 Day 1 (Anti-IL-2 Antibodies)
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported.
- groups
- description
- Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG000
- title
- Lead-In Part: E7777 6 mcg/kg
- description
- Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
- id
- OG001
- title
- Lead-In Part: E7777 9 mcg/kg
- description
- Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG002
- title
- Lead-In Part: E7777 12 mcg/kg
- description
- Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG003
- title
- Lead-In Part: E7777 15 mcg/kg
- param Type
- NUMBER
- population Description
- Lead-in PK Analysis Set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
- title
- Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice