TriangleNCT03215030 · OUTCOME
Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanograms per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
What was measured
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Analysis population: The Pharmacokinetic (PK) Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Groups in this outcome
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg
Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Participants received Modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 6 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 6 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 3 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 6 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 6 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 14.7 | 47.6 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 154 | 95.5 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 2980 | 29.0 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 11800 | 33.5 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 1260 | 106.1 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 2230 | 53.8 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 2460 | 38.6 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 15000 | 20.0 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 11600 | 30.9 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 15900 | 27.1 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 16.9 | 75.4 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 289 | 71.8 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 2750 | 18.1 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 11900 | 40.8 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 1030 | 183.5 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 2600 | 37.9 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 5 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 47.5 | 175.1 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 158 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 3030 | 10.1 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 1970 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 2490 | 41.5 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 15100 | 2.3 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 9690 | 21.3 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 16800 | 31.3 | Not reported | Not reported | Not reported |
Cycle 2 Day 15
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 1730 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 1270 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 47.6
- value
- 14.7
- group Id
- OG001
- spread
- 95.5
- value
- 154
- group Id
- OG002
- spread
- 29.0
- value
- 2980
- group Id
- OG003
- spread
- 33.5
- value
- 11800
- group Id
- OG004
- spread
- 106.1
- value
- 1260
- group Id
- OG005
- spread
- 53.8
- value
- 2230
- group Id
- OG006
- spread
- 38.6
- value
- 2460
- group Id
- OG007
- spread
- 20.0
- value
- 15000
- group Id
- OG008
- spread
- 30.9
- value
- 11600
- group Id
- OG009
- spread
- 27.1
- value
- 15900
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 75.4
- value
- 16.9
- group Id
- OG001
- spread
- 71.8
- value
- 289
- group Id
- OG002
- spread
- 18.1
- value
- 2750
- group Id
- OG003
- spread
- 40.8
- value
- 11900
- group Id
- OG004
- spread
- 183.5
- value
- 1030
- group Id
- OG005
- spread
- 37.9
- value
- 2600
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 175.1
- value
- 47.5
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG001
- spread
- NA
- value
- 158
- group Id
- OG002
- spread
- 10.1
- value
- 3030
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG005
- spread
- NA
- value
- 1970
- group Id
- OG006
- spread
- 41.5
- value
- 2490
- group Id
- OG007
- spread
- 2.3
- value
- 15100
- group Id
- OG008
- spread
- 21.3
- value
- 9690
- group Id
- OG009
- spread
- 31.3
- value
- 16800
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 2
- units
- Participants
- title
- Cycle 2 Day 1
- categories
- measurements
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG004
- spread
- NA
- value
- 1730
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG005
- spread
- NA
- value
- 1270
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- units
- Participants
- title
- Cycle 2 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 3
- units
- Participants
- description
- As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg
- description
- Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
- description
- Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
- description
- Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
- description
- Participants received Modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG004
- title
- Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
- description
- Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG005
- title
- Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
- description
- Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG006
- title
- Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
- description
- Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG007
- title
- Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
- description
- Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG008
- title
- Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
- description
- Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG009
- title
- Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- The Pharmacokinetic (PK) Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
- reporting Status
- POSTED
- time Frame
- Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
- title
- Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice