Trial · NCT01761240
Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
NCT01761240, Phase 1, Completed, Morphotek; results first posted 2024-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC. Trials, record NCT01761240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01761240
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
- NCT number
- NCT01761240
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 27 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Interventions
- MORAb-066
- First posted
- 2013-01-04
- Last updated
- 2024-03-29
- Results first posted
- 2024-03-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months) | 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. |
| Secondary | Number of Participants With Dose Limiting Toxicity (DLT) | Cycle 1 (Cycle length=28 days) | 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. |
| Secondary | Maximum Tolerated Dose (MTD) | Cycle 1 (Cycle length=28 days) | 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. |
| Secondary | Cmax: Maximum Observed Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | Tmax: Time to Reach Maximum Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | t1/2: Terminal Elimination Phase Half-Life for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | Vd: Volume of Distribution for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | CL: Total Body Clearance for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months) | The safety analysis set was the group of participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Dose Limiting Toxicity (DLT) | Cycle 1 (Cycle length=28 days) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Tolerated Dose (MTD) | Cycle 1 (Cycle length=28 days) | 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. | mg/kg | NUMBER |
| SECONDARY | Cmax: Maximum Observed Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | 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. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Tmax: Time to Reach Maximum Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | 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. | hours | MEDIAN |
| SECONDARY | t1/2: Terminal Elimination Phase Half-Life for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | 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. | hours | MEAN |
| SECONDARY | AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | 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. | hours*microgram/milliliter | MEAN |
| SECONDARY | AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | 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. | hour*microgram per milliliter | MEAN |
| SECONDARY | Vd: Volume of Distribution for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | 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. | liter | MEAN |
| SECONDARY | CL: Total Body Clearance for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | 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. | liter per hour | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 0.1 mg/kg | TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 0.3 mg/kg | TEAEs | 4 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 1 mg/kg | TEAEs | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 2 mg/kg | TEAEs | 7 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 3 mg/kg | TEAEs | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 0.1 mg/kg | SAEs | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 0.3 mg/kg | SAEs | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 1 mg/kg | SAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 2 mg/kg | SAEs | 4 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | MORAb-066 3 mg/kg | SAEs | 3 | Participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MORAb-066 0.1 mg/kg | 3 | |
| Overall Study | STARTED | MORAb-066 0.3 mg/kg | 4 | |
| Overall Study | STARTED | MORAb-066 1 mg/kg | 5 | |
| Overall Study | STARTED | MORAb-066 2 mg/kg | 7 | |
| Overall Study | STARTED | MORAb-066 3 mg/kg | 8 | |
| Overall Study | COMPLETED | MORAb-066 0.1 mg/kg | 0 | |
| Overall Study | COMPLETED | MORAb-066 0.3 mg/kg | 0 | |
| Overall Study | COMPLETED | MORAb-066 1 mg/kg | 0 | |
| Overall Study | COMPLETED | MORAb-066 2 mg/kg | 0 | |
| Overall Study | COMPLETED | MORAb-066 3 mg/kg | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events560
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | MORAb-066 0.1 mg/kg | 1 | 3 | |
| other | Vomiting | Gastrointestinal disorders | MORAb-066 0.3 mg/kg | 2 | 4 | |
| other | Vomiting | Gastrointestinal disorders | MORAb-066 1 mg/kg | 4 | 5 | |
| other | Vomiting | Gastrointestinal disorders | MORAb-066 2 mg/kg | 3 | 7 | |
| other | Vomiting | Gastrointestinal disorders | MORAb-066 3 mg/kg | 1 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | MORAb-066 0.1 mg/kg | 2 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | MORAb-066 0.3 mg/kg | 2 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | MORAb-066 1 mg/kg | 0 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | MORAb-066 2 mg/kg | 1 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | MORAb-066 3 mg/kg | 1 | 8 |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MORAb-066 0.1 mg/kg | 0 | 3 |
| Total, all-cause mortality | MORAb-066 0.3 mg/kg | 1 | 4 |
| Total, all-cause mortality | MORAb-066 1 mg/kg | 1 | 5 |
| Total, all-cause mortality | MORAb-066 2 mg/kg | 2 | 7 |
| Total, all-cause mortality | MORAb-066 3 mg/kg | 1 | 8 |
| Total, other adverse events | MORAb-066 0.1 mg/kg | 3 | 3 |
| Total, other adverse events | MORAb-066 0.3 mg/kg | 4 | 4 |
| Total, other adverse events | MORAb-066 1 mg/kg | 5 | 5 |
| Total, other adverse events | MORAb-066 2 mg/kg | 7 | 7 |
| Total, other adverse events | MORAb-066 3 mg/kg | 8 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01761240
GET https://conductscience.org/api/trials/v1/NCT01761240/results?page=2