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NCT04628780 · OUTCOME

Number of Participants by Anti-IL-15 Wild Type NAb Categories

Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors · Source last updated 2024-07-29

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. N1=Number of participants with ≥ 1 post-treatment NAb result; n=Number of NAb evaluable participants with positive NAb at baseline; n2=Number of NAb-positive participants (treatment induced).

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 NAb 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PF-07209960 1 mg SC4
PF-07209960 3 mg SC3
PF-07209960 10 mg SC4
PF-07209960 15 mg SC3
PF-07209960 20 mg SC14
PF-07209960 30 mg SC5

Reported measurements

Evaluable participants with pre-existing antibody, n/N1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC0Not reportedNot reportedNot reportedNot reported
Overall Incidence, n2/N1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Evaluable participants with pre-existing antibody, n/N1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
    title
    Overall Incidence, n2/N1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      14
    6. 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. N1=Number of participants with ≥ 1 post-treatment NAb result; n=Number of NAb evaluable participants with positive NAb at baseline; n2=Number of NAb-positive participants (treatment induced).
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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 NAb 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 Anti-IL-15 Wild Type NAb Categories
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice