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NCT05061537 · OUTCOME

Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
From Baseline (pre-dose) on Day 1 up to Day 22

What was measured

A participant was considered NAb positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive neutralizing antibodies against PF-07263689 is presented in this outcome measure. Data was not collected for sasanlimab as no participants were enrolled in Part 1b of the study.

Analysis population: Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

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

GroupSource count
Part 1A PF-07263689 2*10^8 PFU3
Part 1A PF-07263689 6*10^8 PFU4
Part 1A PF-07263689 20*10^8PFU6

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1A PF-07263689 2*10^8 PFU66.7Not reportedNot reportedNot reportedNot reported
Part 1A PF-07263689 6*10^8 PFU50.0Not reportedNot reportedNot reportedNot reported
Part 1A PF-07263689 20*10^8PFU100.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        66.7
      2. group Id
        OG001
        value
        50.0
      3. group Id
        OG002
        value
        100.0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      6
    units
    Participants
description
A participant was considered NAb positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive neutralizing antibodies against PF-07263689 is presented in this outcome measure. Data was not collected for sasanlimab as no participants were enrolled in Part 1b of the study.
groups
  1. 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
  2. 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
  3. 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
NUMBER
population Description
Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
reporting Status
POSTED
time Frame
From Baseline (pre-dose) on Day 1 up to Day 22
title
Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice