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NCT02798536 · OUTCOME

Number of Participants at Recommended Phase 2 Dose (RP2D) With Partial or Complete Response by the Response Evaluation Criteria in Solid Tumors (RECIST)

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
End of treatment, an average of 57.6 days

What was measured

Number of participants at maximum tolerated dose (MTD) with partial or complete response measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Groups in this outcome

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: 140mcg LMB-1007
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel11

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level -1: 140mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level -1: 140mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Number of participants at maximum tolerated dose (MTD) with partial or complete response measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
groups
  1. 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
    OG000
    title
    Dose Level -1: 140mcg LMB-100
  2. 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
    OG001
    title
    Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
End of treatment, an average of 57.6 days
title
Number of Participants at Recommended Phase 2 Dose (RP2D) With Partial or Complete Response by the Response Evaluation Criteria in Solid Tumors (RECIST)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice