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NCT04034238 · OUTCOME

Maximum Tolerated Dose (MTD) of LMB-100 With Tofacitinib

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
NUMBER
Unit
mcg/kg given days 4, 6, 8 every cycle
Interval / dispersion
Not reported
Time frame
First cycle of treatment (21 days)

What was measured

MTD is defined as the maximum dose at which less than 33% of participants experience a dose-limiting toxicity (defined as any events occurring within the first cycle of treatment (21 days) such as any death not clearly due to the underlying disease or extraneous causes).

Groups in this outcome

All Participants in Dose Escalation Dose Level 1, and Dose Level 2

All Participants in Dose Escalation Dose Level 1, and Dose Level 2 administered LMB-100: Both Arms intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 and Tofacitinib orally twice daily on days 1-10 of each cycle, and LMB-100.

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

Analysis denominator · Participants

GroupSource count
All Participants in Dose Escalation Dose Level 1, and Dose Level 210

Reported measurements

Source class 1
Values in mcg/kg given days 4, 6, 8 every cycle · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants in Dose Escalation Dose Level 1, and Dose Level 2100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
MTD is defined as the maximum dose at which less than 33% of participants experience a dose-limiting toxicity (defined as any events occurring within the first cycle of treatment (21 days) such as any death not clearly due to the underlying disease or extraneous causes).
groups
  1. description
    All Participants in Dose Escalation Dose Level 1, and Dose Level 2 administered LMB-100: Both Arms intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 and Tofacitinib orally twice daily on days 1-10 of each cycle, and LMB-100.
    id
    OG000
    title
    All Participants in Dose Escalation Dose Level 1, and Dose Level 2
param Type
NUMBER
reporting Status
POSTED
time Frame
First cycle of treatment (21 days)
title
Maximum Tolerated Dose (MTD) of LMB-100 With Tofacitinib
type
PRIMARY
unit Of Measure
mcg/kg given days 4, 6, 8 every cycle

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

Preserved source evidence · Not medical advice