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NCT05061537 · OUTCOME

Part 1: Objective Response Rate

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
95% Confidence Interval
Time frame
From first dose of study treatment until CR or PR (up to maximum follow-up of 10.45 months)

What was measured

ORR was defined as the percentage of participants with a best overall response of CR or PR and was determined using RECIST version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. 95% confidence interval (CI) was based on Clopper-Pearson method.

Analysis population: Response evaluable set included all participants who received at least one dose of study treatment and had baseline disease assessment \[or measurable disease at baseline, if applicable\] and at least one post-baseline disease assessment. 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 PFU3
Part 1A PF-07263689 20*10^8PFU4

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1A PF-07263689 2*10^8 PFU0Not reported0.070.8Not reported
Part 1A PF-07263689 6*10^8 PFU0Not reported0.070.8Not reported
Part 1A PF-07263689 20*10^8PFU0Not reported0.060.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        60.2
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    units
    Participants
description
ORR was defined as the percentage of participants with a best overall response of CR or PR and was determined using RECIST version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. 95% confidence interval (CI) was based on Clopper-Pearson method.
dispersion Type
95% Confidence Interval
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
Response evaluable set included all participants who received at least one dose of study treatment and had baseline disease assessment \[or measurable disease at baseline, if applicable\] and at least one post-baseline disease assessment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
reporting Status
POSTED
time Frame
From first dose of study treatment until CR or PR (up to maximum follow-up of 10.45 months)
title
Part 1: Objective Response Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice