TriangleNCT02526017 · OUTCOME
PK of Cabiralizumab: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin)
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
- 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 method. Cmax is the maximum observed serum concentration of cabiralizumab during the dosing period. Cmin is the minimum observed serum concentration of cabiralizumab during a dosing interval (excluding pre-dose concentration before the first dose).
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
Cmax 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 | 52.11 | 10.663 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg Q2W | 104.82 | 21.543 | Not reported | Not reported | Not reported |
| Cabiralizumab 6 mg/kg Q2W | 142.83 | 38.528 | Not reported | Not reported | Not reported |
| Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | 21.93 | 7.651 | Not reported | Not reported | Not reported |
| Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 49.00 | 17.314 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 104.47 | 6.890 | Not reported | Not reported | Not reported |
| Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 124.36 | 8.825 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 85.45 | 16.750 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 93.41 | 25.708 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 93.69 | 23.406 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 83.01 | 37.646 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 81.40 | 17.451 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 102.62 | 23.863 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 87.42 | 22.209 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 103.09 | 18.816 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 92.06 | 13.515 | Not reported | Not reported | Not reported |
Cmin 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 | 2.68 | 2.223 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg Q2W | 28.61 | 17.127 | Not reported | Not reported | Not reported |
| Cabiralizumab 6 mg/kg Q2W | 37.08 | 18.490 | Not reported | Not reported | Not reported |
| Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | 3.29 | 4.414 | Not reported | Not reported | Not reported |
| Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 3.96 | 2.711 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 25.57 | 16.098 | Not reported | Not reported | Not reported |
| Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 28.76 | 5.307 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 10.34 | 8.351 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 16.22 | 10.176 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 17.82 | 10.054 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 13.65 | 6.959 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 15.45 | 9.663 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 25.07 | 12.496 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 14.19 | 9.111 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 31.96 | 16.282 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 17.75 | 12.316 | Not reported | Not reported | Not reported |
Cmax 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 | 187.27 | 63.438 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 126.01 | 39.937 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 142.85 | 44.856 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 97.24 | 25.252 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 108.76 | 24.249 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 130.17 | 29.845 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 121.06 | 40.392 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 167.66 | 47.960 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 164.47 | 15.283 | Not reported | Not reported | Not reported |
Cmin 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 | 109.66 | 58.420 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 38.79 | 20.999 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 52.26 | 6.642 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 37.05 | 13.674 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 40.63 | 11.189 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 36.95 | 15.291 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 40.15 | 16.612 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 85.33 | 30.039 | Not reported | Not reported | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 82.00 | 12.572 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 10.663
- value
- 52.11
- group Id
- OG001
- spread
- 21.543
- value
- 104.82
- group Id
- OG002
- spread
- 38.528
- value
- 142.83
- group Id
- OG003
- spread
- 7.651
- value
- 21.93
- group Id
- OG004
- spread
- 17.314
- value
- 49.00
- group Id
- OG005
- spread
- 6.890
- value
- 104.47
- group Id
- OG006
- spread
- 8.825
- value
- 124.36
- group Id
- OG007
- spread
- 16.750
- value
- 85.45
- group Id
- OG008
- spread
- 25.708
- value
- 93.41
- group Id
- OG009
- spread
- 23.406
- value
- 93.69
- group Id
- OG010
- spread
- 37.646
- value
- 83.01
- group Id
- OG011
- spread
- 17.451
- value
- 81.40
- 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
- Cmax Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 2.223
- value
- 2.68
- group Id
- OG001
- spread
- 17.127
- value
- 28.61
- group Id
- OG002
- spread
- 18.490
- value
- 37.08
- group Id
- OG003
- spread
- 4.414
- value
- 3.29
- group Id
- OG004
- spread
- 2.711
- value
- 3.96
- group Id
- OG005
- spread
- 16.098
- value
- 25.57
- group Id
- OG006
- spread
- 5.307
- value
- 28.76
- group Id
- OG007
- spread
- 8.351
- value
- 10.34
- group Id
- OG008
- spread
- 10.176
- value
- 16.22
- group Id
- OG009
- spread
- 10.054
- value
- 17.82
- group Id
- OG010
- spread
- 6.959
- value
- 13.65
- group Id
- OG011
- spread
- 9.663
- value
- 15.45
- 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
- Cmin Cycle 1
- categories
- measurements
- group Id
- OG006
- spread
- 63.438
- value
- 187.27
- group Id
- OG008
- spread
- 39.937
- value
- 126.01
- group Id
- OG009
- spread
- 44.856
- value
- 142.85
- group Id
- OG010
- spread
- 25.252
- value
- 97.24
- group Id
- OG011
- spread
- 24.249
- value
- 108.76
- group Id
- OG012
- spread
- 29.845
- value
- 130.17
- group Id
- OG013
- spread
- 40.392
- value
- 121.06
- group Id
- OG014
- spread
- 47.960
- value
- 167.66
- group Id
- OG015
- spread
- 15.283
- value
- 164.47
- 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
- Cmax Cycle 8
- categories
- measurements
- group Id
- OG006
- spread
- 58.420
- value
- 109.66
- group Id
- OG008
- spread
- 20.999
- value
- 38.79
- group Id
- OG009
- spread
- 6.642
- value
- 52.26
- group Id
- OG010
- spread
- 13.674
- value
- 37.05
- group Id
- OG011
- spread
- 11.189
- value
- 40.63
- group Id
- OG012
- spread
- 15.291
- value
- 36.95
- group Id
- OG013
- spread
- 16.612
- value
- 40.15
- group Id
- OG014
- spread
- 30.039
- value
- 85.33
- group Id
- OG015
- spread
- 12.572
- value
- 82.00
- 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
- Cmin 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 method. Cmax is the maximum observed serum concentration of cabiralizumab during the dosing period. Cmin is the minimum observed serum concentration of cabiralizumab during a dosing interval (excluding pre-dose concentration before the first dose).
- 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
- PK of Cabiralizumab: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin)
- type
- SECONDARY
- unit Of Measure
- µg/mL
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Preserved source evidence · Not medical advice