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NCT05061537 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    title
    Part 1A PF-07263689 20*10^8PFU
  4. description
    Participants were planned to receive escalating doses of PF-07263689 in combination with sasanlimab.
    id
    FG003
    title
    Part 1B: PF-07263689 + Sasanlimab
  5. description
    Participants were planned to receive PF-07263689 in combination with sasanlimab at the preliminary combination recommended Phase 2 dose from Part 1B.
    id
    FG004
    title
    Part 2: PF-07263689 + Sasanlimab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Global deterioration of health status
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. comment
        Eligible participants attended follow-up visit 28 to 90 days after discontinuation of study treatment.
        group Id
        FG001
        num Subjects
        3
      3. comment
        Eligible participants attended follow-up visit 28 to 90 days after discontinuation of study treatment.
        group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow up
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Study terminated by sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. comment
        Eligible participants entered long term follow-up for survival.
        group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. comment
        Eligible participants entered long term follow-up for survival.
        group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Long-term Follow-up
pre Assignment Details
A total of 13 participants were enrolled in Part 1A of the study.
recruitment Details
Study was planned to be conducted in 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and combination with sasanlimab (Part 1B) and Part 2 dose expansion for the combination therapy. The study was terminated during Part 1A due to sponsor's business decision; hence, Part 1B and Part 2 were not conducted and no participants were enrolled in Part 1B and 2.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    title
    Part 1A PF-07263689 20*10^8PFU
  4. description
    Participants were planned to receive escalating doses of PF-07263689 in combination with sasanlimab.
    id
    FG003
    title
    Part 1B: PF-07263689 + Sasanlimab
  5. description
    Participants were planned to receive PF-07263689 in combination with sasanlimab at the preliminary combination recommended Phase 2 dose from Part 1B.
    id
    FG004
    title
    Part 2: PF-07263689 + Sasanlimab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Global deterioration of health status
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. comment
        Eligible participants attended follow-up visit 28 to 90 days after discontinuation of study treatment.
        group Id
        FG001
        num Subjects
        3
      3. comment
        Eligible participants attended follow-up visit 28 to 90 days after discontinuation of study treatment.
        group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow up
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Study terminated by sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. comment
        Eligible participants entered long term follow-up for survival.
        group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. comment
        Eligible participants entered long term follow-up for survival.
        group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Long-term Follow-up
pre Assignment Details
A total of 13 participants were enrolled in Part 1A of the study.
recruitment Details
Study was planned to be conducted in 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and combination with sasanlimab (Part 1B) and Part 2 dose expansion for the combination therapy. The study was terminated during Part 1A due to sponsor's business decision; hence, Part 1B and Part 2 were not conducted and no participants were enrolled in Part 1B and 2.

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Preserved source evidence · Not medical advice