Trial Outcomes & Findings for Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers (NCT NCT03801915)
NCT ID: NCT03801915
Last Updated: 2023-03-21
Results Overview
Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.
COMPLETED
PHASE2
10 participants
1 year
2023-03-21
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Enrolled But Not Treated
Enrolled But Not Treated
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
1
|
1
|
|
Overall Study
COMPLETED
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Enrolled But Not Treated
Enrolled But Not Treated
|
|---|---|---|---|
|
Overall Study
Screen failure
|
0
|
0
|
1
|
|
Overall Study
Ineligible
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
Baseline Characteristics
Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
Baseline characteristics by cohort
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
n=8 Participants
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
n=1 Participants
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Enrolled But Not Treated
n=1 Participants
Enrolled But Not Treated
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Age, Continuous
|
64.75 years
STANDARD_DEVIATION 6.39 • n=99 Participants
|
69.7 years
STANDARD_DEVIATION 0 • n=107 Participants
|
48.8 years
STANDARD_DEVIATION 0 • n=206 Participants
|
63.65 years
STANDARD_DEVIATION 7.84 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
10 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 yearDisease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.
Outcome measures
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
n=8 Participants
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
n=1 Participants
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
|---|---|---|
|
Number of Participants With Disease Recurrence At 1 Year
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.
Outcome measures
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
n=8 Participants
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
n=1 Participants
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
|---|---|---|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 5 Adverse Event - Not Related
|
0 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Abdominal pain - Not Related
|
2 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Abdominal infection - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Alanine aminotransferase increased - Not Related
|
2 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Alkaline phosphatase increased - Not Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Anemia - Not Related
|
5 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Aspartate aminotransferase increased - Not Related
|
3 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Back pain - Not Related
|
2 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Blood bilirubin increased - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Confusion - Not Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Dyspnea - Not Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hematuria - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hepatobiliary disorders- Other, Bile duct perforation - Not Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hyperglycemia - Not Related
|
2 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hypermagnesemia - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hypertension - Not Related
|
5 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hypoalbuminemia - Not Related
|
3 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hypokalemia - Not Related
|
3 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hyponatremia - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Hypotension - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Lymphocyte count decreased - Not Related
|
4 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Pharyngitis - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Thromboembolic event - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Urine output decreased - Not Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Vomiting - Not Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Alkaline phosphatase increased - Related
|
2 Adverse events
|
4 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Anemia - Related
|
3 Adverse events
|
3 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Aspartate aminotransferase increased - Related
|
6 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Alanine aminotransferase increased - Related
|
3 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Blood bilirubin increased - Related
|
1 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 3 Lymphocyte count decreased - Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 4 Aspartate aminotransferase increased - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 4 Lymphocyte count increased - Not Related
|
1 Adverse events
|
0 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 4 Alkaline phosphatase increased - Related
|
0 Adverse events
|
1 Adverse events
|
|
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Grade 5 Adverse Event - Related
|
0 Adverse events
|
0 Adverse events
|
SECONDARY outcome
Timeframe: An average of 15.17 monthsPopulation: 5/8 participants were analyzed in cohort 1 because 2 participants were found to have peritoneal metastases on Day 0 and were taken off study, and 1 participant was taken off study due to study closure.
Disease free survival is defined as resection day of surgery Day 0 (D0) until the time of documented clinical recurrence (radiographically or pathologically). In the absence of a knowable time of recurrence, time of death will be used as a surrogate. Clinical recurrence is cancer that has recurred during which the cancer could not be detected. This is judged on computed tomography (CT) or magnetic resonance imaging (MRI) as compared to the scan obtained after surgery and completion of the study drug.
Outcome measures
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
n=5 Participants
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
n=1 Participants
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
|---|---|---|
|
Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873
|
14.5 months
Interval 1.0 to 28.0
|
22 months
Full range cannot be calculated because the participant was taken off study due to study closure.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
n=8 Participants
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
n=1 Participants
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
7 Participants
|
1 Participants
|
Adverse Events
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
Serious adverse events
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
n=8 participants at risk
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
n=1 participants at risk
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Gastrointestinal disorders
Gastric ulcer
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, Bile duct perforation
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
Other adverse events
| Measure |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
n=8 participants at risk
Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
n=1 participants at risk
Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.
|
|---|---|---|
|
Infections and infestations
Abdominal infection
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Alanine aminotransferase increased
|
75.0%
6/8 • Number of events 16 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
4/8 • Number of events 11 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
6/8 • Number of events 24 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 11 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Aspartate aminotransferase increased
|
62.5%
5/8 • Number of events 21 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Blood bilirubin increased
|
37.5%
3/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Creatinine increased
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Vascular disorders
Hypertension
|
50.0%
4/8 • Number of events 17 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.5%
3/8 • Number of events 14 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Vascular disorders
Hypotension
|
25.0%
2/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Vascular disorders
Lymph leakage
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
4/8 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Infections and infestations
Thrush
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Renal and urinary disorders
Urinary retention
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Renal and urinary disorders
Urine output decreased
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Cardiac disorders
Ventricular tachycardia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
|
Investigations
White blood cell decreased
|
37.5%
3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place