TriangleNCT02561962 · OUTCOME
Number of Participants With Anti-AMG 224 Antibodies
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
What was measured
The number of participants who tested positive for pre-existing binding antibodies prior to exposure to AMG 224 and who tested positive for anti-AMG 224 binding antibodies after dosing with AMG 224 are presented. Participants with transient post-baseline results were binding antibody positive post-baseline with a negative or no result at baseline and a negative result at the participant's last timepoint tested.
Analysis population: The safety analysis set included all participants who received at least 1 dose of AMG 224.
Groups in this outcome
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
| Group | Source count |
|---|---|
| Dose Exploration: AMG 224 Dose A | 3 |
| Dose Exploration: AMG 224 Dose B | 3 |
| Dose Exploration: AMG 224 Dose C | 3 |
| Dose Exploration: AMG 224 Dose D | 3 |
| Dose Exploration: AMG 224 Dose E | 6 |
| Dose Exploration: AMG 224 Dose F | 6 |
| Dose Exploration: AMG 224 Dose G | 5 |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 9 |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 2 |
Reported measurements
Binding antibody positive at anytime
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
Binding antibody positive at/before baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
Binding antibody positive post-baseline with a negative/no result at baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
Binding antibody positive post-baseline with a negative/no result at baseline: Transient
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 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
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- title
- Binding antibody positive at anytime
- 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
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- title
- Binding antibody positive at/before baseline
- 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
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- Binding antibody positive post-baseline with a negative/no result at baseline
- 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
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Binding antibody positive post-baseline with a negative/no result at baseline: Transient
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 2
- units
- Participants
- description
- The number of participants who tested positive for pre-existing binding antibodies prior to exposure to AMG 224 and who tested positive for anti-AMG 224 binding antibodies after dosing with AMG 224 are presented. Participants with transient post-baseline results were binding antibody positive post-baseline with a negative or no result at baseline and a negative result at the participant's last timepoint tested.
- groups
- description
- Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG000
- title
- Dose Exploration: AMG 224 Dose A
- description
- Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG001
- title
- Dose Exploration: AMG 224 Dose B
- description
- Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG002
- title
- Dose Exploration: AMG 224 Dose C
- description
- Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG003
- title
- Dose Exploration: AMG 224 Dose D
- description
- Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG004
- title
- Dose Exploration: AMG 224 Dose E
- description
- Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG005
- title
- Dose Exploration: AMG 224 Dose F
- description
- Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG006
- title
- Dose Exploration: AMG 224 Dose G
- description
- Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG007
- title
- Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
- description
- Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG008
- title
- Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
- param Type
- NUMBER
- population Description
- The safety analysis set included all participants who received at least 1 dose of AMG 224.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
- title
- Number of Participants With Anti-AMG 224 Antibodies
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice