TriangleNCT05787496 · OUTCOME
Maximum Observed Serum Concentration (Cmax) of NC525
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- μg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days)
What was measured
To evaluate the maximum observed serum concentration (Cmax) of NC525. The values reported are Cmax at Cycle 2 Day 1.
Analysis population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis.
Groups in this outcome
2mg/kg NC525
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
2.5mg/kg NC525
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
4.5mg/kg NC525
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
9mg/kg NC525
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
13.5mg/kg NC525
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
18mg/kg NC525
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
| Group | Source count |
|---|---|
| 2mg/kg NC525 | 3 |
| 2.5mg/kg NC525 | 4 |
| 4.5mg/kg NC525 | 3 |
| 9mg/kg NC525 | 9 |
| 13.5mg/kg NC525 | 4 |
| 18mg/kg NC525 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 2mg/kg NC525 | 26.1 | 10.6 | Not reported | Not reported | Not reported |
| 2.5mg/kg NC525 | 58.8 | 36.5 | Not reported | Not reported | Not reported |
| 4.5mg/kg NC525 | 106 | 16.3 | Not reported | Not reported | Not reported |
| 9mg/kg NC525 | 268 | 107 | Not reported | Not reported | Not reported |
| 13.5mg/kg NC525 | 445 | 178 | Not reported | Not reported | Not reported |
| 18mg/kg NC525 | 585 | 176 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 10.6
- value
- 26.1
- group Id
- OG001
- spread
- 36.5
- value
- 58.8
- group Id
- OG002
- spread
- 16.3
- value
- 106
- group Id
- OG003
- spread
- 107
- value
- 268
- group Id
- OG004
- spread
- 178
- value
- 445
- group Id
- OG005
- spread
- 176
- value
- 585
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- To evaluate the maximum observed serum concentration (Cmax) of NC525. The values reported are Cmax at Cycle 2 Day 1.
- dispersion Type
- Standard Deviation
- groups
- description
- Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG000
- title
- 2mg/kg NC525
- description
- Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG001
- title
- 2.5mg/kg NC525
- description
- Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG002
- title
- 4.5mg/kg NC525
- description
- Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG003
- title
- 9mg/kg NC525
- description
- Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG004
- title
- 13.5mg/kg NC525
- description
- Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG005
- title
- 18mg/kg NC525
- param Type
- MEAN
- population Description
- The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis.
- reporting Status
- POSTED
- time Frame
- During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days)
- title
- Maximum Observed Serum Concentration (Cmax) of NC525
- type
- SECONDARY
- unit Of Measure
- μg/mL
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Preserved source evidence · Not medical advice