NCT05061537 · OUTCOME
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose
Study of PF-07263689 in Participants With Selected Advanced Solid Tumors · Source last updated 2024-04-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Copies per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- At 30, 45 and 60 days post last dose of study treatment (up to 24 days of treatment exposure)
What was measured
Viral titers in each matrix (saliva, urine and skin swabs \[30 days post last dose only\]) at 30, 45 and 60 days after last dose of study treatment is reported in this outcome measure.
Analysis population: Vector Shedding Analysis Set included all enrolled participants who were treated and had at least 1 analyte concentration above the lower limit of quantitation. Data is not reported for Part 1b as no participants were enrolled and data was not collected. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and contributed data to the table and 'Number Analyzed' signifies participants evaluable for the specified time points.
Groups in this outcome
Part 1A PF-07263689 2*10^8 PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1A PF-07263689 6*10^8 PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1A PF-07263689 20*10^8PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
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 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 4 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 6 |
|---|
Reported measurements
Saliva; 30 days post last dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 1 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 0 |
|---|
Values in Copies per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
Saliva; 45 days post last dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 1 |
|---|
Values in Copies per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 20*10^8PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
Saliva; 60 days post last dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 0 |
|---|
Values in Copies per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
Skin swab; 30 days post last dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 1 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 0 |
|---|
Values in Copies per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
Urine; 30 days post last dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 1 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 0 |
|---|
Values in Copies per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
Urine; 45 days post last dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 1 |
|---|
Values in Copies per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 20*10^8PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
Urine; 60 days post last dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1A PF-07263689 2*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 6*10^8 PFU | 3 |
|---|
| Part 1A PF-07263689 20*10^8PFU | 0 |
|---|
Values in Copies per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1A PF-07263689 2*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
| Part 1A PF-07263689 6*10^8 PFU | NA | NA | Not reported | Not reported | Data could not be calculated as the values were below the limit of quantification. |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Saliva; 30 days post last dose
- categories
- measurements
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG002
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Saliva; 45 days post last dose
- categories
- measurements
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Saliva; 60 days post last dose
- categories
- measurements
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Skin swab; 30 days post last dose
- categories
- measurements
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Urine; 30 days post last dose
- categories
- measurements
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG002
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Urine; 45 days post last dose
- categories
- measurements
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Data could not be calculated as the values were below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Urine; 60 days post last dose
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Viral titers in each matrix (saliva, urine and skin swabs \[30 days post last dose only\]) at 30, 45 and 60 days after last dose of study treatment is reported in this outcome measure.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- OG000
- title
- Part 1A PF-07263689 2*10^8 PFU
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- OG001
- title
- Part 1A PF-07263689 6*10^8 PFU
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- OG002
- title
- Part 1A PF-07263689 20*10^8PFU
- param Type
- MEAN
- population Description
- Vector Shedding Analysis Set included all enrolled participants who were treated and had at least 1 analyte concentration above the lower limit of quantitation. Data is not reported for Part 1b as no participants were enrolled and data was not collected. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and contributed data to the table and 'Number Analyzed' signifies participants evaluable for the specified time points.
- reporting Status
- POSTED
- time Frame
- At 30, 45 and 60 days post last dose of study treatment (up to 24 days of treatment exposure)
- title
- Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose
- type
- SECONDARY
- unit Of Measure
- Copies per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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