NCT02573259 · OUTCOME
Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1
A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Percentage of Baseline
- Interval / dispersion
- Full Range
- Time frame
- Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing)
What was measured
PD-1 RO by sasanlimab was measured by the reduction of free receptor on the surface of CD8+ effector cells (CD3+, CD4-, CD8+, CD45RA+, CCR7-, CD279+) and CD8+ effector memory cells (CD3+, CD4-, CD8+, CD45RA-, CCR7-, CD279+) presented in pre- and postdose whole blood samples by flow cytometry. Percentage of baseline (ie, normalized change from baseline) PD-1 RO were calculated as \[(percentage of cells at Cycle X Day X)/(percentage of cells at baseline)\]\*100, and are reported for this outcome measure. Baseline was defined as the most recent non-missing value prior to dosing.
Analysis population: Analysis population included all enrolled participants with at least 1 of the pharmacodynamic/biomarker parameters evaluated at pre- and/or post dose.
Groups in this outcome
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
Part 1: PF-06801591 1 mg/kg (IV)
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
Part 1: PF-06801591 3 mg/kg (IV)
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
Part 1: PF-06801591 10 mg/kg (IV)
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 8 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 7 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 15 |
|---|
Reported measurements
Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 8 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 7 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 13 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.1 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.56 | Not reported | 0.0 | 4.0 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.02 | Not reported | 0.0 | 0.6 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.32 | Not reported | 0.0 | 3.0 | Not reported |
|---|
Cycle 1 Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 15 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.2 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 1.4 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.00 | Not reported | 0.0 | 3.1 | Not reported |
|---|
Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 7 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 12 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 1.3 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.6 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 7.7 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.57 | Not reported | 0.0 | 4.5 | Not reported |
|---|
Cycle 1 Day 21
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 13 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.00 | Not reported | 0.0 | 1.0 | Not reported |
|---|
Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 5 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 5 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 14 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 1.48 | Not reported | 0.0 | 3.0 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.04 | Not reported | 0.0 | 1.7 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.82 | Not reported | 0.0 | 3.0 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 1.0 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.00 | Not reported | 0.0 | 4.7 | Not reported |
|---|
Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 4 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 5 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 11 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.2 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.47 | Not reported | 0.0 | 3.1 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 2.3 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.00 | Not reported | 0.0 | 4.7 | Not reported |
|---|
Cycle 4 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 8 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 5 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 7 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0.80 | Not reported | 0.5 | 1.1 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.05 | Not reported | 0.0 | 23.2 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 2.1 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.00 | Not reported | 0.0 | 2.1 | Not reported |
|---|
Cycle 4 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 3 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 2 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 6 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 2.6 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.7 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.00 | Not reported | 0.0 | 1.4 | Not reported |
|---|
Cycle 4 Day 21
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 5 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 1.31 | Not reported | 0.0 | 1.4 | Not reported |
|---|
Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 4 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 5 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 5 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 15 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.0 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.00 | Not reported | 0.0 | 3.2 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 1.2 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.00 | Not reported | 0.0 | 1.5 | Not reported |
|---|
EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 6 |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 4 |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 4 |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 10 |
|---|
Values in Percentage of Baseline · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: PF-06801591 1 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.5 | Not reported |
|---|
| Part 1: PF-06801591 3 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.7 | Not reported |
|---|
| Part 1: PF-06801591 10 mg/kg (IV) | 0.00 | Not reported | 0.0 | 0.5 | Not reported |
|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0.17 | Not reported | 0.0 | 2.7 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.1
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 4.0
- value
- 0.56
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.6
- value
- 0.02
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 3.0
- value
- 0.32
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 13
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.2
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 1.4
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 3.1
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 15
- units
- Participants
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 1.3
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.6
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 7.7
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 4.5
- value
- 0.57
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 12
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 1.0
- value
- 0.00
- 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
- 13
- units
- Participants
- title
- Cycle 1 Day 21
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 3.0
- value
- 1.48
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 1.7
- value
- 0.04
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 3.0
- value
- 0.82
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 1.0
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 4.7
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 14
- units
- Participants
- title
- Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.2
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 3.1
- value
- 0.47
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 2.3
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 4.7
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 11
- units
- Participants
- title
- Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 1.1
- value
- 0.80
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 23.2
- value
- 0.05
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 2.1
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 2.1
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- units
- Participants
- title
- Cycle 4 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 2.6
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.7
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 1.4
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 6
- units
- Participants
- title
- Cycle 4 Day 15
- categories
- measurements
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 1.4
- value
- 1.31
- 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
- 5
- units
- Participants
- title
- Cycle 4 Day 21
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 3.2
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 1.2
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 1.5
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 15
- units
- Participants
- title
- Cycle 5 Day 1
- categories
- measurements
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.5
- value
- 0.00
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.7
- value
- 0.00
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.5
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 2.7
- value
- 0.17
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 10
- units
- Participants
- title
- EOT
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 15
- units
- Participants
- description
- PD-1 RO by sasanlimab was measured by the reduction of free receptor on the surface of CD8+ effector cells (CD3+, CD4-, CD8+, CD45RA+, CCR7-, CD279+) and CD8+ effector memory cells (CD3+, CD4-, CD8+, CD45RA-, CCR7-, CD279+) presented in pre- and postdose whole blood samples by flow cytometry. Percentage of baseline (ie, normalized change from baseline) PD-1 RO were calculated as \[(percentage of cells at Cycle X Day X)/(percentage of cells at baseline)\]\*100, and are reported for this outcome measure. Baseline was defined as the most recent non-missing value prior to dosing.
- dispersion Type
- Full Range
- groups
- description
- Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
- id
- OG000
- title
- Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
- description
- Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
- id
- OG001
- title
- Part 1: PF-06801591 1 mg/kg (IV)
- description
- Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
- id
- OG002
- title
- Part 1: PF-06801591 3 mg/kg (IV)
- description
- Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
- id
- OG003
- title
- Part 1: PF-06801591 10 mg/kg (IV)
- description
- Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
- id
- OG004
- title
- Part 1: PF-06801591 300 mg (Subcutaneously [SC])
- param Type
- MEDIAN
- population Description
- Analysis population included all enrolled participants with at least 1 of the pharmacodynamic/biomarker parameters evaluated at pre- and/or post dose.
- reporting Status
- POSTED
- time Frame
- Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing)
- title
- Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1
- type
- SECONDARY
- unit Of Measure
- Percentage of Baseline
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Preserved source evidence · Not medical advice
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