TriangleNCT02526017 · OUTCOME
Pharmacokinetics (PK) of Cabiralizumab: Area Under the Concentration Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Normalized by Dose (Phase 1a and 1b)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- days*µg/mL/mg
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycles 1 and 8, Day 1 predose, and at 0.25, 4, 24, 72, 168, and 336 hours after the end of infusion.
What was measured
Cabiralizumab serum concentration was determined using a validated enzyme-linked immunosorbent assay (ELISA) method.
Analysis population: The PK evaluable population included participants who received at least 1 dose of cabiralizumab, had at least 1 available serum concentration data, and adequate PK assessments which could be used to reliably derive at least 1 PK parameter. Not all participants completed 8 cycles. PK data are reported by treatment regimen for Phase 1a participants and by disease type for Phase 1b participants.
Groups in this outcome
Cabiralizumab 2 mg/kg Q2W
Participants with any solid tumor received 2 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg Q2W
Participants with any solid tumor received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 6 mg/kg Q2W
Participants with any solid tumor received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
Participants with any solid tumor received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
Participants with any solid tumor received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
Participants with any solid tumor received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
Participants with any solid tumor received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W
Participants with any solid tumor received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q3W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)
Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)
Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN
Participants with SCCHN received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer
Participants with pancreatic cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer
Participants with advanced ovarian cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC
Participants with RCC received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM
Participants with malignant glioma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma
Participants with melanoma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
| Group | Source count |
|---|---|
| Cabiralizumab 2 mg/kg Q2W | 3 |
| Cabiralizumab 4 mg/kg Q2W | 10 |
| Cabiralizumab 6 mg/kg Q2W | 9 |
| Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | 4 |
| Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 3 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 3 |
| Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 5 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 10 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 27 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 29 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 27 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 63 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 26 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 10 |
Reported measurements
Cycle 1
| Group | Source count |
|---|---|
| Cabiralizumab 2 mg/kg Q2W | 3 |
| Cabiralizumab 4 mg/kg Q2W | 10 |
| Cabiralizumab 6 mg/kg Q2W | 9 |
| Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | 4 |
| Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 3 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 3 |
| Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 5 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 10 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 27 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 29 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 27 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 63 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 26 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabiralizumab 2 mg/kg Q2W | 1.26 | 0.588 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg Q2W | 1.70 | 0.444 | Not reported | Not reported | Not reported |
| Cabiralizumab 6 mg/kg Q2W | 1.84 | 0.684 | Not reported | Not reported | Not reported |
| Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | 0.66 | 0.346 | Not reported | Not reported | Not reported |
| Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 1.22 | 0.970 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 1.66 | 0.737 | Not reported | Not reported | Not reported |
| Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 2.14 | 0.509 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 1.75 | 0.982 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 1.74 | 0.769 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 1.46 | 0.562 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 1.42 | 0.404 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 1.52 | 0.494 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 1.95 | 0.753 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 1.31 | 0.460 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 2.09 | 0.733 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 1.48 | 0.587 | Not reported | Not reported | Not reported |
Cycle 8
| Group | Source count |
|---|---|
| Cabiralizumab 2 mg/kg Q2W | 0 |
| Cabiralizumab 4 mg/kg Q2W | 0 |
| Cabiralizumab 6 mg/kg Q2W | 0 |
| Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | 0 |
| Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 0 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 0 |
| Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 2 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 0 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 7 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 4 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 8 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 8 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 4 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 8 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 6 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 3.65 | 0.696 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 2.83 | 1.602 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 3.52 | 1.290 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 2.63 | 1.128 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 2.32 | 0.694 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 2.69 | 1.307 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 2.67 | 2.120 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 4.69 | 2.058 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 4.43 | 1.126 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.588
- value
- 1.26
- group Id
- OG001
- spread
- 0.444
- value
- 1.70
- group Id
- OG002
- spread
- 0.684
- value
- 1.84
- group Id
- OG003
- spread
- 0.346
- value
- 0.66
- group Id
- OG004
- spread
- 0.970
- value
- 1.22
- group Id
- OG005
- spread
- 0.737
- value
- 1.66
- group Id
- OG006
- spread
- 0.509
- value
- 2.14
- group Id
- OG007
- spread
- 0.982
- value
- 1.75
- group Id
- OG008
- spread
- 0.769
- value
- 1.74
- group Id
- OG009
- spread
- 0.562
- value
- 1.46
- group Id
- OG010
- spread
- 0.404
- value
- 1.42
- group Id
- OG011
- spread
- 0.494
- value
- 1.52
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 27
- group Id
- OG009
- value
- 29
- group Id
- OG010
- value
- 27
- group Id
- OG011
- value
- 63
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG006
- spread
- 0.696
- value
- 3.65
- group Id
- OG008
- spread
- 1.602
- value
- 2.83
- group Id
- OG009
- spread
- 1.290
- value
- 3.52
- group Id
- OG010
- spread
- 1.128
- value
- 2.63
- group Id
- OG011
- spread
- 0.694
- value
- 2.32
- group Id
- OG012
- spread
- 1.307
- value
- 2.69
- group Id
- OG013
- spread
- 2.120
- value
- 2.67
- group Id
- OG014
- spread
- 2.058
- value
- 4.69
- group Id
- OG015
- spread
- 1.126
- value
- 4.43
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 8
- group Id
- OG011
- value
- 8
- units
- Participants
- title
- Cycle 8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 27
- group Id
- OG009
- value
- 29
- group Id
- OG010
- value
- 27
- group Id
- OG011
- value
- 63
- units
- Participants
- description
- Cabiralizumab serum concentration was determined using a validated enzyme-linked immunosorbent assay (ELISA) method.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with any solid tumor received 2 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG000
- title
- Cabiralizumab 2 mg/kg Q2W
- description
- Participants with any solid tumor received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG001
- title
- Cabiralizumab 4 mg/kg Q2W
- description
- Participants with any solid tumor received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG002
- title
- Cabiralizumab 6 mg/kg Q2W
- description
- Participants with any solid tumor received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG003
- title
- Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
- description
- Participants with any solid tumor received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG004
- title
- Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
- description
- Participants with any solid tumor received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG005
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
- description
- Participants with any solid tumor received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG006
- title
- Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
- description
- Participants with any solid tumor received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q3W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG007
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W
- description
- Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG008
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)
- description
- Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG009
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)
- description
- Participants with SCCHN received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG010
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN
- description
- Participants with pancreatic cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG011
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer
- param Type
- MEAN
- population Description
- The PK evaluable population included participants who received at least 1 dose of cabiralizumab, had at least 1 available serum concentration data, and adequate PK assessments which could be used to reliably derive at least 1 PK parameter. Not all participants completed 8 cycles. PK data are reported by treatment regimen for Phase 1a participants and by disease type for Phase 1b participants.
- reporting Status
- POSTED
- time Frame
- Cycles 1 and 8, Day 1 predose, and at 0.25, 4, 24, 72, 168, and 336 hours after the end of infusion.
- title
- Pharmacokinetics (PK) of Cabiralizumab: Area Under the Concentration Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Normalized by Dose (Phase 1a and 1b)
- type
- SECONDARY
- unit Of Measure
- days*µg/mL/mg
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Preserved source evidence · Not medical advice