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NCT02798536 · OUTCOME

Number of Participants With Anti-drug Antibodies (ADAs) Formation to LMB-100

Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma · Source last updated 2022-08-23

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
Cycle 1 and Cycle 2 (each cycle is 21 days), approximately 42 days

What was measured

ADAs formation to LMB-100 were measured by the enzyme-linked immunosorbent assay (ELISA). The presence of ADAs (i.e., positive) may indicate the participant may have poor blood levels.

Groups in this outcome

Dose Level 1: 170mcg LMB-100

Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.

Dose Level -1: 140mcg LMB-100

Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.

Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel

Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.

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

Analysis denominator · Participants

GroupSource count
Dose Level 1: 170mcg LMB-1003
Dose Level -1: 140mcg LMB-1007
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel10

Reported measurements

Cycle 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 170mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Dose Level -1: 140mcg LMB-1002Not reportedNot reportedNot reportedNot reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel3Not reportedNot reportedNot reportedNot reported
Cycle 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 170mcg LMB-1003Not reportedNot reportedNot reportedNot reported
Dose Level -1: 140mcg LMB-1005Not reportedNot reportedNot reportedNot reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel5Not reportedNot reportedNot reportedNot reported
No ADA formation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 170mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Dose Level -1: 140mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    No ADA formation
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      10
    units
    Participants
description
ADAs formation to LMB-100 were measured by the enzyme-linked immunosorbent assay (ELISA). The presence of ADAs (i.e., positive) may indicate the participant may have poor blood levels.
groups
  1. description
    Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
    id
    OG000
    title
    Dose Level 1: 170mcg LMB-100
  2. description
    Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
    id
    OG001
    title
    Dose Level -1: 140mcg LMB-100
  3. description
    Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
    id
    OG002
    title
    Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Cycle 1 and Cycle 2 (each cycle is 21 days), approximately 42 days
title
Number of Participants With Anti-drug Antibodies (ADAs) Formation to LMB-100
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice