TriangleNCT04628780 · OUTCOME
Number of Participants by Antidrug Antibody (ADA) Categories
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
What was measured
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n1=Number of ADA evaluable participants with positive ADA at baseline but did not become boosted post-treatment; n2=Number of ADA-positive participants (treatment-induced or treatment-boosted).
Analysis population: Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment ADA result (N1).
Groups in this outcome
PF-07209960 1 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
PF-07209960 3 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
PF-07209960 10 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
PF-07209960 15 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
PF-07209960 20 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
PF-07209960 30 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
| Group | Source count |
|---|---|
| PF-07209960 1 mg SC | 4 |
| PF-07209960 3 mg SC | 3 |
| PF-07209960 10 mg SC | 4 |
| PF-07209960 15 mg SC | 3 |
| PF-07209960 20 mg SC | 14 |
| PF-07209960 30 mg SC | 5 |
Reported measurements
Evaluable participants with pre-existing antibody, n/N1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 3 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 10 mg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 15 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 20 mg SC | 6 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 30 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
Baseline-positive participants with non-boosted antibody response, n1/N1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 3 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 10 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 15 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 20 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 30 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
Overall Incidence, n2/N1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 3 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 10 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 15 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 20 mg SC | 13 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 30 mg SC | 5 | Not reported | Not reported | Not reported | Not reported |
Treatment-induced
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 3 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 10 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 15 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 20 mg SC | 8 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 30 mg SC | 4 | Not reported | Not reported | Not reported | Not reported |
Treatment-boosted
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 3 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 10 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 15 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 20 mg SC | 5 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 30 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 1
- title
- Evaluable participants with pre-existing antibody, n/N1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Baseline-positive participants with non-boosted antibody response, n1/N1
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 5
- title
- Overall Incidence, n2/N1
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 4
- title
- Treatment-induced
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- title
- Treatment-boosted
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 5
- units
- Participants
- description
- Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n1=Number of ADA evaluable participants with positive ADA at baseline but did not become boosted post-treatment; n2=Number of ADA-positive participants (treatment-induced or treatment-boosted).
- groups
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
- id
- OG000
- title
- PF-07209960 1 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
- id
- OG001
- title
- PF-07209960 3 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
- id
- OG002
- title
- PF-07209960 10 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
- id
- OG003
- title
- PF-07209960 15 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
- id
- OG004
- title
- PF-07209960 20 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
- id
- OG005
- title
- PF-07209960 30 mg SC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment ADA result (N1).
- reporting Status
- POSTED
- time Frame
- on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
- title
- Number of Participants by Antidrug Antibody (ADA) Categories
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice