NCT04034238 · OUTCOME

Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)) 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: h*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

AUC is a measure of the serum concentration of LMB-100 over time. It is used to characterize drug absorption.

Analysis population: 3/16 participants from both cohorts were not analyzed they did not have AUC(INF) 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 h*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg	2415.9	1041.2	Not reported	Not reported	Not reported
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg	2918.5	2434.6	Not reported	Not reported	Not reported
Dose Expansion LMB-100, 100 mcg/kg	2804.1	190.14	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1041.2
value
2415.9
group Id
OG001
spread
2434.6
value
2918.5
group Id
OG002
spread
190.14
value
2804.1

denoms

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

description

AUC is a measure of the serum concentration of LMB-100 over time. It is used to characterize drug absorption.

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 from both cohorts were not analyzed they did not have AUC(INF) 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

Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)) of LMB-100

type

SECONDARY

unit Of Measure

h*ng/mL

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Preserved source evidence · Not medical advice