Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04034238 · OUTCOME

Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors · Source last updated 2023-08-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-administration, end-of-infusion, then 1, 2, 4, 8-10, 12-16 hours post- LMB-100 during cycle 1 (each cycle = 21 days)

What was measured

The maximum observed analyte concentration in plasma was reported.

Analysis population: 1/6 participants from the expansion cohort were not evaluable because they discontinued treatment before receiving LMB-100 during their 1st cycle.

Groups in this outcome

Dose Escalation Dose Level 1 LMB-100 100 mcg/kg

LMB-100 100 mcg/kg LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study. Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.

Dose Escalation Dose Level 2 LMB-100 140 mcg/kg

LMB-100 140 mcg/kg LMB-100: Arms 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study. Tofacitinib: Arms 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.

Dose Expansion LMB-100, 100 mcg/kg

LMB-100 at optimal dose plus tofacitinib - 100 mcg/kg LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study. Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from 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
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg7
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg3
Dose Expansion LMB-100, 100 mcg/kg5

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg1644.43343.08Not reportedNot reportedNot reported
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg2160.67797.9Not reportedNot reportedNot reported
Dose Expansion LMB-100, 100 mcg/kg1466.4257.25Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        343.08
        value
        1644.43
      2. group Id
        OG001
        spread
        797.9
        value
        2160.67
      3. group Id
        OG002
        spread
        257.25
        value
        1466.4
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      5
    units
    Participants
description
The maximum observed analyte concentration in plasma was reported.
dispersion Type
Standard Deviation
groups
  1. description
    LMB-100 100 mcg/kg LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study. Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.
    id
    OG000
    title
    Dose Escalation Dose Level 1 LMB-100 100 mcg/kg
  2. description
    LMB-100 140 mcg/kg LMB-100: Arms 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study. Tofacitinib: Arms 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.
    id
    OG001
    title
    Dose Escalation Dose Level 2 LMB-100 140 mcg/kg
  3. description
    LMB-100 at optimal dose plus tofacitinib - 100 mcg/kg LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study. Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.
    id
    OG002
    title
    Dose Expansion LMB-100, 100 mcg/kg
param Type
MEAN
population Description
1/6 participants from the expansion cohort were not evaluable because they discontinued treatment before receiving LMB-100 during their 1st cycle.
reporting Status
POSTED
time Frame
Pre-administration, end-of-infusion, then 1, 2, 4, 8-10, 12-16 hours post- LMB-100 during cycle 1 (each cycle = 21 days)
title
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice