TriangleNCT03386513 · OUTCOME
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms (µg)/milliliter (mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 and Cycle 3 (each cycle length = 21 days)
Analysis population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.
Groups in this outcome
Schedule A: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.045 mg/kg
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.09 mg/kg
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.18 mg/kg
Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.3 mg/kg
Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.45 mg/kg
Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule B: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Schedule B: IMGN632 0.03 mg/kg
Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Schedule B: IMGN632 0.06 mg/kg
Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 2 |
| Schedule A: IMGN632 0.045 mg/kg | 107 |
| Schedule A: IMGN632 0.09 mg/kg | 23 |
| Schedule A: IMGN632 0.18 mg/kg | 7 |
| Schedule A: IMGN632 0.3 mg/kg | 5 |
| Schedule A: IMGN632 0.45 mg/kg | 2 |
| Schedule B: IMGN632 0.015 mg/kg | 2 |
| Schedule B: IMGN632 0.03 mg/kg | 6 |
| Schedule B: IMGN632 0.06 mg/kg | 13 |
Reported measurements
IMGN632 ADC: Cycle 1
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 2 |
| Schedule A: IMGN632 0.045 mg/kg | 107 |
| Schedule A: IMGN632 0.09 mg/kg | 23 |
| Schedule A: IMGN632 0.18 mg/kg | 7 |
| Schedule A: IMGN632 0.3 mg/kg | 5 |
| Schedule A: IMGN632 0.45 mg/kg | 2 |
| Schedule B: IMGN632 0.015 mg/kg | 2 |
| Schedule B: IMGN632 0.03 mg/kg | 6 |
| Schedule B: IMGN632 0.06 mg/kg | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0.0291 | 669 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.045 mg/kg | 0.442 | 122 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 1.08 | 68 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.18 mg/kg | 2.69 | 26 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.3 mg/kg | 4.64 | 42 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.45 mg/kg | 8.44 | 21 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.015 mg/kg | 0.0247 | 72 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 0.396 | 234 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.06 mg/kg | 0.405 | 120 | Not reported | Not reported | Not reported |
Total Antibody: Cycle 1
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 1 |
| Schedule A: IMGN632 0.045 mg/kg | 94 |
| Schedule A: IMGN632 0.09 mg/kg | 23 |
| Schedule A: IMGN632 0.18 mg/kg | 7 |
| Schedule A: IMGN632 0.3 mg/kg | 5 |
| Schedule A: IMGN632 0.45 mg/kg | 2 |
| Schedule B: IMGN632 0.015 mg/kg | 0 |
| Schedule B: IMGN632 0.03 mg/kg | 6 |
| Schedule B: IMGN632 0.06 mg/kg | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0.160 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable with n=1 |
| Schedule A: IMGN632 0.045 mg/kg | 0.611 | 143 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 0.978 | 105 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.18 mg/kg | 2.79 | 37 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.3 mg/kg | 4.87 | 45 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.45 mg/kg | 7.36 | 21 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 0.439 | 256 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.06 mg/kg | 0.415 | 108 | Not reported | Not reported | Not reported |
IMGN632 ADC: Cycle 3
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 1 |
| Schedule A: IMGN632 0.045 mg/kg | 72 |
| Schedule A: IMGN632 0.09 mg/kg | 3 |
| Schedule A: IMGN632 0.18 mg/kg | 0 |
| Schedule A: IMGN632 0.3 mg/kg | 0 |
| Schedule A: IMGN632 0.45 mg/kg | 0 |
| Schedule B: IMGN632 0.015 mg/kg | 2 |
| Schedule B: IMGN632 0.03 mg/kg | 3 |
| Schedule B: IMGN632 0.06 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0.0789 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable with n=1 |
| Schedule A: IMGN632 0.045 mg/kg | 0.564 | 105 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 2.08 | 127 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.015 mg/kg | 0.0291 | 1831 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 0.480 | 43 | Not reported | Not reported | Not reported |
Total Antibody: Cycle 3
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0 |
| Schedule A: IMGN632 0.045 mg/kg | 66 |
| Schedule A: IMGN632 0.09 mg/kg | 3 |
| Schedule A: IMGN632 0.18 mg/kg | 0 |
| Schedule A: IMGN632 0.3 mg/kg | 0 |
| Schedule A: IMGN632 0.45 mg/kg | 0 |
| Schedule B: IMGN632 0.015 mg/kg | 1 |
| Schedule B: IMGN632 0.03 mg/kg | 3 |
| Schedule B: IMGN632 0.06 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.045 mg/kg | 0.607 | 81 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 2.03 | 146 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.015 mg/kg | 0.167 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable with n=1 |
| Schedule B: IMGN632 0.03 mg/kg | 0.457 | 28 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 669
- value
- 0.0291
- group Id
- OG001
- spread
- 122
- value
- 0.442
- group Id
- OG002
- spread
- 68
- value
- 1.08
- group Id
- OG003
- spread
- 26
- value
- 2.69
- group Id
- OG004
- spread
- 42
- value
- 4.64
- group Id
- OG005
- spread
- 21
- value
- 8.44
- group Id
- OG006
- spread
- 72
- value
- 0.0247
- group Id
- OG007
- spread
- 234
- value
- 0.396
- group Id
- OG008
- spread
- 120
- value
- 0.405
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 107
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 13
- units
- Participants
- title
- IMGN632 ADC: Cycle 1
- categories
- measurements
- comment
- Geometric Coefficient of Variation not calculable with n=1
- group Id
- OG000
- spread
- NA
- value
- 0.160
- group Id
- OG001
- spread
- 143
- value
- 0.611
- group Id
- OG002
- spread
- 105
- value
- 0.978
- group Id
- OG003
- spread
- 37
- value
- 2.79
- group Id
- OG004
- spread
- 45
- value
- 4.87
- group Id
- OG005
- spread
- 21
- value
- 7.36
- group Id
- OG007
- spread
- 256
- value
- 0.439
- group Id
- OG008
- spread
- 108
- value
- 0.415
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 12
- units
- Participants
- title
- Total Antibody: Cycle 1
- categories
- measurements
- comment
- Geometric Coefficient of Variation not calculable with n=1
- group Id
- OG000
- spread
- NA
- value
- 0.0789
- group Id
- OG001
- spread
- 105
- value
- 0.564
- group Id
- OG002
- spread
- 127
- value
- 2.08
- group Id
- OG006
- spread
- 1831
- value
- 0.0291
- group Id
- OG007
- spread
- 43
- value
- 0.480
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 72
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- IMGN632 ADC: Cycle 3
- categories
- measurements
- group Id
- OG001
- spread
- 81
- value
- 0.607
- group Id
- OG002
- spread
- 146
- value
- 2.03
- comment
- Geometric Coefficient of Variation not calculable with n=1
- group Id
- OG006
- spread
- NA
- value
- 0.167
- group Id
- OG007
- spread
- 28
- value
- 0.457
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 66
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Total Antibody: Cycle 3
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 107
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 13
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG004
- title
- Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG006
- title
- Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG007
- title
- Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG008
- title
- Schedule B: IMGN632 0.06 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.
- reporting Status
- POSTED
- time Frame
- Cycle 1 and Cycle 3 (each cycle length = 21 days)
- title
- Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody
- type
- SECONDARY
- unit Of Measure
- micrograms (µg)/milliliter (mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice