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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

1 year

Results posted on

2023-03-21

Participant Flow

Participant milestones

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

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

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 year

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.

Outcome measures

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

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 months

Population: 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

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

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)

Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths

Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

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

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

Dr. Jonathan Hernandez

National Cancer Institute

Phone: 240-760-6072

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place