TriangleNCT02460224 · OUTCOME
Phase 1: Number of Participants With Anti-LAG525 Antibodies
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
- Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
What was measured
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Analysis population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable. Japanese patients were analyzed together with the rest of the world (ROW) patients.
Groups in this outcome
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 14 |
| Phase 1: LAG525 3 mg/kg Q2W | 11 |
| Phase 1: LAG525 5 mg/kg Q2W | 4 |
| Phase 1: LAG525 10 mg/kg Q2W | 5 |
| Phase 1: LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W | 21 |
| Phase 1: LAG525 400 mg Q2W | 17 |
| Phase 1: LAG525 3 mg/kg Q4W | 4 |
| Phase 1: LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 5 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 15 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 3 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 8 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 6 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 3 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 9 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 10 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 5 |
Reported measurements
ADA-negative at baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 14 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q2W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 15 mg/kg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W | 19 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q2W | 15 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q4W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 12 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
ADA-positive at post-baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q2W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 15 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q4W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 15
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- title
- ADA-negative at baseline
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 3
- title
- ADA-positive at post-baseline
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 17
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 7
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
- groups
- description
- Single-agent LAG525 1 mg/kg Q2W
- id
- OG000
- title
- Phase 1: LAG525 1 mg/kg Q2W
- description
- Single-agent LAG525 3 mg/kg Q2W
- id
- OG001
- title
- Phase 1: LAG525 3 mg/kg Q2W
- description
- Single-agent LAG525 5 mg/kg Q2W
- id
- OG002
- title
- Phase 1: LAG525 5 mg/kg Q2W
- description
- Single-agent LAG525 10 mg/kg Q2W
- id
- OG003
- title
- Phase 1: LAG525 10 mg/kg Q2W
- description
- Single-agent LAG525 15 mg/kg Q2W
- id
- OG004
- title
- Phase 1: LAG525 15 mg/kg Q2W
- description
- Single-agent LAG525 240 mg Q2W
- id
- OG005
- title
- Phase 1: LAG525 240 mg Q2W
- description
- Single-agent LAG525 400 mg Q2W
- id
- OG006
- title
- Phase 1: LAG525 400 mg Q2W
- description
- Single-agent LAG525 3 mg/kg Q4W
- id
- OG007
- title
- Phase 1: LAG525 3 mg/kg Q4W
- description
- Single-agent LAG525 5 mg/kg Q4W
- id
- OG008
- title
- Phase 1: LAG525 5 mg/kg Q4W
- description
- Single-agent LAG525 10 mg/kg Q4W
- id
- OG009
- title
- Phase 1: LAG525 10 mg/kg Q4W
- description
- Single-agent LAG525 400 mg Q4W
- id
- OG010
- title
- Phase 1: LAG525 400 mg Q4W
- description
- Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
- id
- OG011
- title
- Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients in phase 1 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable. Japanese patients were analyzed together with the rest of the world (ROW) patients.
- reporting Status
- POSTED
- time Frame
- Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
- title
- Phase 1: Number of Participants With Anti-LAG525 Antibodies
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice