TriangleNCT00819169 · OUTCOME
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
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
- Time from first dose up to 24 months
Analysis population: Antibody Population = All subjects in the full analysis set tested for antibodies during the study.
Groups in this outcome
Part 1 Cohort 1
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 1 Cohort 2
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 1 Cohort 3
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 2 Cohort 1
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
Part 2 Cohort 2
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
Part 2 Cohort 3
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
Part 2 Cohort 4
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
Part 2 Cohort 5
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
Part 2 Cohort 6
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
| Group | Source count |
|---|---|
| Part 1 Cohort 1 | 1 |
| Part 1 Cohort 2 | 2 |
| Part 1 Cohort 3 | 1 |
| Part 2 Cohort 1 | 11 |
| Part 2 Cohort 2 | 5 |
| Part 2 Cohort 3 | 13 |
| Part 2 Cohort 4 | 7 |
| Part 2 Cohort 5 | 7 |
| Part 2 Cohort 6 | 10 |
Reported measurements
AMG 655 - Binding antibody positive at any time
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
AMG 655 - Neutralizing antibody positive at any time
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
AMG 479 - Binding antibody positive at any time
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
AMG 479 - Neutralizing antibody positive at any time
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- 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
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- AMG 655 - Binding antibody positive at any time
- 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
- title
- AMG 655 - Neutralizing antibody positive at any time
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- 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
- title
- AMG 479 - Binding antibody positive at any time
- 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
- title
- AMG 479 - Neutralizing antibody positive at any time
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 10
- units
- Participants
- groups
- description
- AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG000
- title
- Part 1 Cohort 1
- description
- AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG001
- title
- Part 1 Cohort 2
- description
- AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG002
- title
- Part 1 Cohort 3
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
- id
- OG003
- title
- Part 2 Cohort 1
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
- id
- OG004
- title
- Part 2 Cohort 2
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
- id
- OG005
- title
- Part 2 Cohort 3
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
- id
- OG006
- title
- Part 2 Cohort 4
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
- id
- OG007
- title
- Part 2 Cohort 5
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
- id
- OG008
- title
- Part 2 Cohort 6
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Antibody Population = All subjects in the full analysis set tested for antibodies during the study.
- reporting Status
- POSTED
- time Frame
- Time from first dose up to 24 months
- title
- To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice