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NCT02659631 · OUTCOME

Number of Participants With Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06671008

PF-06671008 Dose Escalation Study in Advanced Solid Tumors · Source last updated 2020-05-06

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
C1D1 0 hrs, D15 0 hrs, and C2D1 0 hrs, and D1 0 hrs post additional dosings, up to 24 months

What was measured

ADA against PF-06671008 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.18 was considered positive.

Analysis population: All enrolled participants who received at least one dose of study intervention and had at least one post dose ADA sample analyzed.

Groups in this outcome

PF-06671008 1.5 ng/kg IV

PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 7.5 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.

PF-06671008 20 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 50 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

PF-06671008 100 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 200 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.

PF-06671008 300 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.

PF-06671008 400 ng/kg IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.

PF-06671008 200 ng/kg SC

PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.

PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV

PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.

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-06671008 1.5 ng/kg IV1
PF-06671008 7.5 ng/kg IV2
PF-06671008 20 ng/kg IV3
PF-06671008 50 ng/kg IV2
PF-06671008 100 ng/kg IV4
PF-06671008 200 ng/kg IV5
PF-06671008 300 ng/kg IV4
PF-06671008 400 ng/kg IV3
PF-06671008 200 ng/kg SC2
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV1

Reported measurements

ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06671008 1.5 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 7.5 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 20 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 50 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 100 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 200 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 300 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 400 ng/kg IV0Not reportedNot reportedNot reportedNot reported
PF-06671008 200 ng/kg SC1Not reportedNot reportedNot reportedNot reported
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV0Not reportedNot reportedNot reportedNot reported
NAb
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06671008 1.5 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 7.5 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 20 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 50 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 100 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 200 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 300 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 400 ng/kg IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 200 ng/kg SCNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IVNANot reportedNot reportedNot reportedNAb samples were not analyzed for this study.
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
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
    title
    ADA
  2. categories
    1. measurements
      1. comment
        NAb samples were not analyzed for this study.
        group Id
        OG000
        value
        NA
      2. comment
        NAb samples were not analyzed for this study.
        group Id
        OG001
        value
        NA
      3. comment
        NAb samples were not analyzed for this study.
        group Id
        OG002
        value
        NA
      4. comment
        NAb samples were not analyzed for this study.
        group Id
        OG003
        value
        NA
      5. comment
        NAb samples were not analyzed for this study.
        group Id
        OG004
        value
        NA
      6. comment
        NAb samples were not analyzed for this study.
        group Id
        OG005
        value
        NA
      7. comment
        NAb samples were not analyzed for this study.
        group Id
        OG006
        value
        NA
      8. comment
        NAb samples were not analyzed for this study.
        group Id
        OG007
        value
        NA
      9. comment
        NAb samples were not analyzed for this study.
        group Id
        OG008
        value
        NA
      10. comment
        NAb samples were not analyzed for this study.
        group Id
        OG009
        value
        NA
    title
    NAb
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      1
    units
    Participants
description
ADA against PF-06671008 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.18 was considered positive.
groups
  1. description
    PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG000
    title
    PF-06671008 1.5 ng/kg IV
  2. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
    id
    OG001
    title
    PF-06671008 7.5 ng/kg IV
  3. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG002
    title
    PF-06671008 20 ng/kg IV
  4. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    OG003
    title
    PF-06671008 50 ng/kg IV
  5. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG004
    title
    PF-06671008 100 ng/kg IV
  6. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
    id
    OG005
    title
    PF-06671008 200 ng/kg IV
  7. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG006
    title
    PF-06671008 300 ng/kg IV
  8. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
    id
    OG007
    title
    PF-06671008 400 ng/kg IV
  9. description
    PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
    id
    OG008
    title
    PF-06671008 200 ng/kg SC
  10. description
    PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
    id
    OG009
    title
    PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
param Type
COUNT_OF_PARTICIPANTS
population Description
All enrolled participants who received at least one dose of study intervention and had at least one post dose ADA sample analyzed.
reporting Status
POSTED
time Frame
C1D1 0 hrs, D15 0 hrs, and C2D1 0 hrs, and D1 0 hrs post additional dosings, up to 24 months
title
Number of Participants With Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06671008
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice