Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.

The safety analysis set was the group of participants who received at least 1 dose of study drug.

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secondary · POSTED

DLT was defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.

The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.

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secondary · POSTED

The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.

The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.

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secondary · POSTED

Cmax: Maximum Observed Serum Concentration for MORAb-066

The pharmacokinetic (PK) analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

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secondary · POSTED

Tmax: Time to Reach Maximum Serum Concentration for MORAb-066

The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

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secondary · POSTED

t1/2: Terminal Elimination Phase Half-Life for MORAb-066

The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

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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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id: NCT01761240
trial label: Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0000
source section id
NCT01761240-om-0000
source outcome index
0
endpoint
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
endpoint definition
Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.
time origin
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The safety analysis set was the group of participants who received at least 1 dose of study drug.
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0001
source section id
NCT01761240-om-0001
source outcome index
1
endpoint
Number of Participants With Dose Limiting Toxicity (DLT)
endpoint definition
DLT was defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.
time origin
Cycle 1 (Cycle length=28 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0002
source section id
NCT01761240-om-0002
source outcome index
2
endpoint
Maximum Tolerated Dose (MTD)
endpoint definition
The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.
time origin
Cycle 1 (Cycle length=28 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0003
source section id
NCT01761240-om-0003
source outcome index
3
endpoint
Cmax: Maximum Observed Serum Concentration for MORAb-066
endpoint definition
Cmax: Maximum Observed Serum Concentration for MORAb-066
time origin
Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The pharmacokinetic (PK) analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0004
source section id
NCT01761240-om-0004
source outcome index
4
endpoint
Tmax: Time to Reach Maximum Serum Concentration for MORAb-066
endpoint definition
Tmax: Time to Reach Maximum Serum Concentration for MORAb-066
time origin
Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0005
source section id
NCT01761240-om-0005
source outcome index
5
endpoint
t1/2: Terminal Elimination Phase Half-Life for MORAb-066
endpoint definition
t1/2: Terminal Elimination Phase Half-Life for MORAb-066
time origin
Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0000
arm key
OG000
arm label
MORAb-066 0.1 mg/kg
regimen
Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0000
arm key
OG001
arm label
MORAb-066 0.3 mg/kg
regimen
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0000
arm key
OG002
arm label
MORAb-066 1 mg/kg
regimen
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0000
arm key
OG003
arm label
MORAb-066 2 mg/kg
regimen
Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0000
arm key
OG004
arm label
MORAb-066 3 mg/kg
regimen
Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0001
arm key
OG000
arm label
MORAb-066 0.1 mg/kg
regimen
Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0001
arm key
OG001
arm label
MORAb-066 0.3 mg/kg
regimen
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0001
arm key
OG002
arm label
MORAb-066 1 mg/kg
regimen
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0001
arm key
OG003
arm label
MORAb-066 2 mg/kg
regimen
Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0001
arm key
OG004
arm label
MORAb-066 3 mg/kg
regimen
Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0002
arm key
OG000
arm label
MORAb-066: All Participants
regimen
Participants received, MORAb-066 0.1 or 0.3 or 1 or 2 or 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in a 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
outcome key
om-0003
arm key
OG000
arm label
MORAb-066 0.1 mg/kg
regimen
Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01761240-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
harm key
EG000
source section id
NCT01761240-ae
event group key
EG000
event group label
MORAb-066 0.1 mg/kg
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
harm key
EG001
source section id
NCT01761240-ae
event group key
EG001
event group label
MORAb-066 0.3 mg/kg
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
harm key
EG002
source section id
NCT01761240-ae
event group key
EG002
event group label
MORAb-066 1 mg/kg
serious affected
3
serious at risk
5
other affected
5
other at risk
5
frequency threshold
0
collection period
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
harm key
EG003
source section id
NCT01761240-ae
event group key
EG003
event group label
MORAb-066 2 mg/kg
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
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-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01761240
harm key
EG004
source section id
NCT01761240-ae
event group key
EG004
event group label
MORAb-066 3 mg/kg
serious affected
3
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
collection period
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
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