NCT04034238 · STUDY IN CONTEXT

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expres

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

Source null

→

primary · POSTED

This measure assessed how many participants have LMB-100 plasma drug levels higher than threshold (600 ng/mL) during Cycle 2 pharmacokinetics (PK) measurements, a sign of effective prevention of anti-LMB-100 antibodies. The validated enzyme-linked immunosorbent assay (ELISA) test was used to measure plasma LMB-100 concentration. Below 600ng/mL is considered a bad outcome and above 600ng/mL is considered a good outcome.

Per protocol, this measure includes all participants who meet eligibility criteria for the dose expansion (pancreatobiliary diagnosis) and received LMB-100 at the Maximum Tolerated Dose (Dose Escalation-Dose Level 1 (DL1) and Dose expansion, n =11). Only participants who have pharmacokinetics results during Cycle 2 are evaluable. Five more participants were not evaluable due to not receiving Cycle 2 treatment or not having pharmacokinetics results.

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primary · POSTED

Grade 1-5 adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 observed in participants with pancreatic cancer. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant. Grade 4 is life-threatening consequences. Grade 5 is death related to adverse events.

Per protocol, this outcome measure was only assessed in the dose escalation dose level 1 and dose escalation dose level 2 groups.

→

secondary · POSTED

This measure assessed how many participants in the dose escalation have LMB-100 plasma drug levels higher than threshold (600 ng/mL) during Cycle 2 pharmacokinetics (PK) measurements, a sign of effective prevention of anti-LMB-100 antibodies. The validated enzyme-linked immunosorbent assay (ELISA) test was used to measure plasma LMB-100 concentration. Below 600ng/mL is considered a bad outcome and above 600ng/mL is considered a good outcome.

6/10 participants were not evaluable for this endpoint because they did not receive the second cycle of treatment.

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secondary · POSTED

The maximum observed analyte concentration in plasma was reported.

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

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secondary · POSTED

This measure assessed how many participants have no LMB-100 plasma drug levels higher than threshold (600 ng/mL) during Cycle 3 pharmacokinetics (PK) measurements, a sign of effective prevention of anti-LMB-100 antibodies. The validated enzyme-linked immunosorbent assay (ELISA) test was used to measure plasma LMB-100 concentration. Below 600ng/mL is considered a bad outcome and above 600ng/mL is considered a good outcome.

12/16 participants were not evaluable because they did not receive a 3rd cycle of treatment.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-bile-duct-cancer-cholangiocarcinoma
nct id: NCT04034238
trial label: Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expres
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0000
source section id
NCT04034238-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD) of LMB-100 With Tofacitinib
endpoint definition
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).
time origin
First cycle of treatment (21 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0001
source section id
NCT04034238-om-0001
source outcome index
1
endpoint
Percentage of Participants With Pancreatobiliary Cancer and LMB-100 Plasma Drug Levels Above Threshold 600ng/mL During Cycle 2 Who Received LMB-100 at Maximum Tolerated Dose
endpoint definition
This measure assessed how many participants have LMB-100 plasma drug levels higher than threshold (600 ng/mL) during Cycle 2 pharmacokinetics (PK) measurements, a sign of effective prevention of anti-LMB-100 antibodies. The validated enzyme-linked immunosorbent assay (ELISA) test was used to measure plasma LMB-100 concentration. Below 600ng/mL is considered a bad outcome and above 600ng/mL is considered a good outcome.
time origin
Plasma LMB-100 levels during Cycle 2 treatment (each cycle = 21 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol, this measure includes all participants who meet eligibility criteria for the dose expansion (pancreatobiliary diagnosis) and received LMB-100 at the Maximum Tolerated Dose (Dose Escalation-Dose Level 1 (DL1) and Dose expansion, n =11). Only participants who have pharmacokinetics results during Cycle 2 are evaluable. Five more participants were not evaluable due to not receiving Cycle 2 treatment or not having pharmacokinetics results.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0002
source section id
NCT04034238-om-0002
source outcome index
2
endpoint
Number of Participants With Serious Adverse Events Possibly, Probably, and/or Definitely Related to LMB-100 Treated in the Dose Escalation Group
endpoint definition
Grade 1-5 adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 observed in participants with pancreatic cancer. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant. Grade 4 is life-threatening consequences. Grade 5 is death related to adverse events.
time origin
Throughout study treatment until 30 days post-completion, approximately 13 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol, this outcome measure was only assessed in the dose escalation dose level 1 and dose escalation dose level 2 groups.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0003
source section id
NCT04034238-om-0003
source outcome index
3
endpoint
Percentage of Participants With LMB-100 Plasma Drug Levels Above Threshold 600ng/mL During Cycle 2 in Dose Escalation
endpoint definition
This measure assessed how many participants in the dose escalation have LMB-100 plasma drug levels higher than threshold (600 ng/mL) during Cycle 2 pharmacokinetics (PK) measurements, a sign of effective prevention of anti-LMB-100 antibodies. The validated enzyme-linked immunosorbent assay (ELISA) test was used to measure plasma LMB-100 concentration. Below 600ng/mL is considered a bad outcome and above 600ng/mL is considered a good outcome.
time origin
Plasma LMB-100 levels during Cycle 2 of treatment (each cycle = 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
6/10 participants were not evaluable for this endpoint because they did not receive the second cycle of treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0004
source section id
NCT04034238-om-0004
source outcome index
4
endpoint
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100
endpoint definition
The maximum observed analyte concentration in plasma was reported.
time origin
Pre-administration, end-of-infusion, then 1, 2, 4, 8-10, 12-16 hours post- LMB-100 during cycle 1 (each cycle = 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
1/6 participants from the expansion cohort were not evaluable because they discontinued treatment before receiving LMB-100 during their 1st cycle.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0005
source section id
NCT04034238-om-0005
source outcome index
5
endpoint
Percentage of Participants Without Delayed Formation of Neutralizing Anti-LMB-100 Anti-drug Antibodies (ADAs)
endpoint definition
This measure assessed how many participants have no LMB-100 plasma drug levels higher than threshold (600 ng/mL) during Cycle 3 pharmacokinetics (PK) measurements, a sign of effective prevention of anti-LMB-100 antibodies. The validated enzyme-linked immunosorbent assay (ELISA) test was used to measure plasma LMB-100 concentration. Below 600ng/mL is considered a bad outcome and above 600ng/mL is considered a good outcome.
time origin
Plasma LMB-100 levels during Cycle 3 treatment (each cycle = 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
12/16 participants were not evaluable because they did not receive a 3rd cycle of treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0000
arm key
OG000
arm label
All Participants in Dose Escalation Dose Level 1, and Dose Level 2
regimen
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.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0001
arm key
OG000
arm label
Dose Expansion LMB-100, 100 mcg/kg
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0002
arm key
OG000
arm label
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0002
arm key
OG001
arm label
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0003
arm key
OG000
arm label
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0003
arm key
OG001
arm label
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg
regimen
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.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0004
arm key
OG000
arm label
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0004
arm key
OG001
arm label
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0004
arm key
OG002
arm label
Dose Expansion LMB-100, 100 mcg/kg
regimen
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.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0004#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0005
arm key
OG000
arm label
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg
regimen
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.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0005
arm key
OG001
arm label
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg
regimen
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.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0005#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
outcome key
om-0005
arm key
OG002
arm label
Dose Expansion LMB-100, 100 mcg/kg
regimen
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.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04034238-om-0005#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
harm key
EG000
source section id
NCT04034238-ae
event group key
EG000
event group label
Dose Escalation Dose Level 1 LMB-100 100 mcg/kg
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
Throughout study treatment until 30 days post-completion, approximately 13 weeks.]
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
harm key
EG001
source section id
NCT04034238-ae
event group key
EG001
event group label
Dose Escalation Dose Level 2 LMB-100 140 mcg/kg
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Throughout study treatment until 30 days post-completion, approximately 13 weeks.]
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04034238
harm key
EG002
source section id
NCT04034238-ae
event group key
EG002
event group label
Dose Expansion LMB-100, 100 mcg/kg
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Throughout study treatment until 30 days post-completion, approximately 13 weeks.]
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice