Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | January 2016 |
End Date: | December 2019 |
Contact: | Paul W Maffuid, PhD |
Email: | clinicaltrials@mabvax.com |
Phone: | 858.259.9405 |
Phase I Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) as Monotherapy and With Chemotherapy in Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies
Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9
Positive Malignancies.
Positive Malignancies.
Open label, multi-center, nonrandomized, dose escalation trial of MVT-5873 to evaluate safety
and determine the MTD and recommended phase II dose of MVT-5873 both as monotherapy (Group A)
and in combination with a standard of care chemotherapy (Group B) in subjects with pancreatic
and other CA19-9 positive malignancies. Both groups will utilize a conventional 3+3 study
design to identify the MTD and recommended phase II dose (RP2D). following determination of
MTD, 10 additional subjects will be treated at the RP2D in each group. The pharmacokinetics
(PK) of MVT-5873 will be determined in each Group.
and determine the MTD and recommended phase II dose of MVT-5873 both as monotherapy (Group A)
and in combination with a standard of care chemotherapy (Group B) in subjects with pancreatic
and other CA19-9 positive malignancies. Both groups will utilize a conventional 3+3 study
design to identify the MTD and recommended phase II dose (RP2D). following determination of
MTD, 10 additional subjects will be treated at the RP2D in each group. The pharmacokinetics
(PK) of MVT-5873 will be determined in each Group.
Inclusion Criteria
1. Signed, informed consent
2. Age 18 or more years
3. Histologically confirmed, locally-advanced or metastatic pancreatic ductal
adenocarcinoma (PDAC) or other CA19-9 positive malignancies
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100%
to 80%
5. Adequate hematologic, hepatic, and renal function
Exclusion Criteria
1. Brain metastases unless previously treated and well controlled for at least 3 months
2. Other known active cancer(s) likely to require treatment in the next two (2) years
3. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy
4. Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal,
investigational, and/or biological therapies and irradiation except for prostate
cancer hormonal therapy, and treatment with MVT-5873 and MVT-2163.
5. Major surgery other than diagnostic surgery within 28 days of Study Day 1
6. History of anaphylactic reaction to human, or humanized, antibody
7. Pregnant or currently breast-feeding
8. Known HIV-positive or Hepatitis C
9. Psychiatric illness/social situations that would interfere with compliance with study
requirements
10. Significant cardiovascular risk including, but not limited to, recent (within 4 weeks)
coronary stenting or myocardial infarction within 6 months
We found this trial at
4
sites
3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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