NCT04034238 · OUTCOME

Plasma Half-Life (T1/2) 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: hour (h)
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

Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.

Analysis population: 3/16 participants were not analyzed because they did not have Plasma Half-life (T1/2) of LMB-100 measured during the 1st cycle (i.e., Not evaluable).

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

Group	Source count
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg	6
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg	2
Dose Expansion LMB-100, 100 mcg/kg	5

Reported measurements

Source class 1

Values in hour (h) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg	1.0	0.39	Not reported	Not reported	Not reported
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg	0.8	0.22	Not reported	Not reported	Not reported
Dose Expansion LMB-100, 100 mcg/kg	1.2	0.25	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.39
value
1.0
group Id
OG001
spread
0.22
value
0.8
group Id
OG002
spread
0.25
value
1.2

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
2
group Id
OG002
value
5
units
Participants

description

Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.

dispersion Type

Standard Deviation

groups

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
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
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

3/16 participants were not analyzed because they did not have Plasma Half-life (T1/2) of LMB-100 measured during the 1st cycle (i.e., Not evaluable).

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

Plasma Half-Life (T1/2) of LMB-100

type

SECONDARY

unit Of Measure

hour (h)

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

Preserved source evidence · Not medical advice