TriangleNCT02669017 · OUTCOME
Maximum Observed Serum Concentration (Cmax) for ADCT-402
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
What was measured
Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Analysis population: Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Groups in this outcome
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 42 |
| Parts 1 and 2: 150 μg/kg Q3W | 88 |
| Part 1: 200 μg/kg Q3W | 14 |
| Part 1: 200 μg/kg Q6W | 22 |
Reported measurements
PBD conjugated Ab: Cycle 1
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 42 |
| Parts 1 and 2: 150 μg/kg Q3W | 88 |
| Part 1: 200 μg/kg Q3W | 14 |
| Part 1: 200 μg/kg Q6W | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 260 | 85.5 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 404 | 161 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 721 | 481 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 1088 | 748 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 2374 | 1040 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 3416 | 3093 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 3619 | 688 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 3798 | 1332 | Not reported | Not reported | Not reported |
PBD conjugated Ab: Cycle 2
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 3 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 40 |
| Parts 1 and 2: 150 μg/kg Q3W | 72 |
| Part 1: 200 μg/kg Q3W | 11 |
| Part 1: 200 μg/kg Q6W | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 398 | 284 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 1971 | 2566 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 864 | 686 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 1416 | 799 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 2573 | 655 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 3776 | 2738 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 4293 | 1021 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 3178 | 1733 | Not reported | Not reported | Not reported |
total Ab: Cycle 1
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 41 |
| Parts 1 and 2: 150 μg/kg Q3W | 88 |
| Part 1: 200 μg/kg Q3W | 14 |
| Part 1: 200 μg/kg Q6W | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 298 | 83.7 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 542 | 192 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 856 | 475 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 1560 | 1102 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 2829 | 1257 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 4383 | 4460 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 4185 | 1308 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 4543 | 1805 | Not reported | Not reported | Not reported |
total Ab: Cycle 2
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 3 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 39 |
| Parts 1 and 2: 150 μg/kg Q3W | 72 |
| Part 1: 200 μg/kg Q3W | 11 |
| Part 1: 200 μg/kg Q6W | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 447 | 283 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 2906 | 4034 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 1275 | 1025 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 2422 | 983 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 3142 | 888 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 4798 | 3334 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 5059 | 1027 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 3834 | 1913 | Not reported | Not reported | Not reported |
SG3199: Cycle 1
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 0 |
| Part 1: 30 μg/kg Q3W | 0 |
| Part 1: 60 μg/kg Q3W | 0 |
| Part 1: 90 μg/kg Q3W | 1 |
| Parts 1 and 2: 120 μg/kg Q3W | 4 |
| Parts 1 and 2: 150 μg/kg Q3W | 28 |
| Part 1: 200 μg/kg Q3W | 4 |
| Part 1: 200 μg/kg Q6W | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 90 μg/kg Q3W | 0.102 | NA | Not reported | Not reported | Standard deviation could not be determined as only one participant had evaluable data. |
| Parts 1 and 2: 120 μg/kg Q3W | 0.0372 | 0.0208 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 0.0570 | 0.0454 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 0.0479 | 0.0381 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 0.0468 | 0.0333 | Not reported | Not reported | Not reported |
SG3199: Cycle 2
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 0 |
| Part 1: 30 μg/kg Q3W | 0 |
| Part 1: 60 μg/kg Q3W | 0 |
| Part 1: 90 μg/kg Q3W | 2 |
| Parts 1 and 2: 120 μg/kg Q3W | 4 |
| Parts 1 and 2: 150 μg/kg Q3W | 15 |
| Part 1: 200 μg/kg Q3W | 3 |
| Part 1: 200 μg/kg Q6W | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 90 μg/kg Q3W | 0.0704 | 0.0152 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 0.0403 | 0.0116 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 0.0485 | 0.0449 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 0.0293 | 0.00329 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 0.0516 | 0.0325 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 85.5
- value
- 260
- group Id
- OG001
- spread
- 161
- value
- 404
- group Id
- OG002
- spread
- 481
- value
- 721
- group Id
- OG003
- spread
- 748
- value
- 1088
- group Id
- OG004
- spread
- 1040
- value
- 2374
- group Id
- OG005
- spread
- 3093
- value
- 3416
- group Id
- OG006
- spread
- 688
- value
- 3619
- group Id
- OG007
- spread
- 1332
- value
- 3798
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 42
- group Id
- OG005
- value
- 88
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 22
- units
- Participants
- title
- PBD conjugated Ab: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 284
- value
- 398
- group Id
- OG001
- spread
- 2566
- value
- 1971
- group Id
- OG002
- spread
- 686
- value
- 864
- group Id
- OG003
- spread
- 799
- value
- 1416
- group Id
- OG004
- spread
- 655
- value
- 2573
- group Id
- OG005
- spread
- 2738
- value
- 3776
- group Id
- OG006
- spread
- 1021
- value
- 4293
- group Id
- OG007
- spread
- 1733
- value
- 3178
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 40
- group Id
- OG005
- value
- 72
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 12
- units
- Participants
- title
- PBD conjugated Ab: Cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 83.7
- value
- 298
- group Id
- OG001
- spread
- 192
- value
- 542
- group Id
- OG002
- spread
- 475
- value
- 856
- group Id
- OG003
- spread
- 1102
- value
- 1560
- group Id
- OG004
- spread
- 1257
- value
- 2829
- group Id
- OG005
- spread
- 4460
- value
- 4383
- group Id
- OG006
- spread
- 1308
- value
- 4185
- group Id
- OG007
- spread
- 1805
- value
- 4543
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 41
- group Id
- OG005
- value
- 88
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 22
- units
- Participants
- title
- total Ab: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 283
- value
- 447
- group Id
- OG001
- spread
- 4034
- value
- 2906
- group Id
- OG002
- spread
- 1025
- value
- 1275
- group Id
- OG003
- spread
- 983
- value
- 2422
- group Id
- OG004
- spread
- 888
- value
- 3142
- group Id
- OG005
- spread
- 3334
- value
- 4798
- group Id
- OG006
- spread
- 1027
- value
- 5059
- group Id
- OG007
- spread
- 1913
- value
- 3834
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 39
- group Id
- OG005
- value
- 72
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 12
- units
- Participants
- title
- total Ab: Cycle 2
- categories
- measurements
- comment
- Standard deviation could not be determined as only one participant had evaluable data.
- group Id
- OG003
- spread
- NA
- value
- 0.102
- group Id
- OG004
- spread
- 0.0208
- value
- 0.0372
- group Id
- OG005
- spread
- 0.0454
- value
- 0.0570
- group Id
- OG006
- spread
- 0.0381
- value
- 0.0479
- group Id
- OG007
- spread
- 0.0333
- value
- 0.0468
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 28
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 16
- units
- Participants
- title
- SG3199: Cycle 1
- categories
- measurements
- group Id
- OG003
- spread
- 0.0152
- value
- 0.0704
- group Id
- OG004
- spread
- 0.0116
- value
- 0.0403
- group Id
- OG005
- spread
- 0.0449
- value
- 0.0485
- group Id
- OG006
- spread
- 0.00329
- value
- 0.0293
- group Id
- OG007
- spread
- 0.0325
- value
- 0.0516
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 4
- units
- Participants
- title
- SG3199: Cycle 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 42
- group Id
- OG005
- value
- 88
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 22
- units
- Participants
- description
- Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG000
- title
- Part 1: 15 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG001
- title
- Part 1: 30 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG002
- title
- Part 1: 60 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG003
- title
- Part 1: 90 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
- id
- OG004
- title
- Parts 1 and 2: 120 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
- id
- OG005
- title
- Parts 1 and 2: 150 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
- id
- OG006
- title
- Part 1: 200 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
- id
- OG007
- title
- Part 1: 200 μg/kg Q6W
- param Type
- MEAN
- population Description
- Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
- reporting Status
- POSTED
- time Frame
- Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
- title
- Maximum Observed Serum Concentration (Cmax) for ADCT-402
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice