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Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies

This study is currently recruiting participants.
Verified August 2017 by MabVax Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02672917
First Posted: February 3, 2016
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
MabVax Therapeutics, Inc.
  Purpose
Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Condition Intervention Phase
Pancreatic Cancer Biological: MVT-5873 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MabVax Therapeutics, Inc.:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) of MVT-5873 as a single agent [ Time Frame: Through study completion. Estimated at one year ]
  • Determine the maximum tolerated dose (MTD) of MVT-5873 in combination with gemcitabine/mab-paclitaxel [ Time Frame: Through study completion. Estimated at one year ]

Secondary Outcome Measures:
  • Assess Response Rate [ Time Frame: Through study completion. Estimated at one year ]
  • Assess Duration of Response [ Time Frame: Through study completion. Estimated at one year ]
  • Determine the adverse event rate for MVT-5873 [ Time Frame: Through study completion. Estimated at one year ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4

  • Determine pharmacokinetics (PK): Area Under the Curve (AUC) for MVT-5873 [ Time Frame: Through study completion. Estimated at one year. ]
    Determined using non-compartmental model.

  • Determine PK: Maximum concentration (Cmax) for MVT-5873 [ Time Frame: Through study completion. Estimated at one year. ]
    Determined using non-compartmental model.

  • Determine PK: Plasma half-life (T1/2) for MVT-5873 [ Time Frame: Through study completion. Estimated at one year. ]
    Determined using non-compartmental model.


Other Outcome Measures:
  • Assess development of anti-MVT-5873 antibodies [ Time Frame: Through study completion. Estimated at one year. ]
    Determined using non-compartmental model.

  • Assess relationship between circulating CA19-9 levels and tumor response [ Time Frame: Through study completion. Estimated at one year. ]
  • Assess relationship between circulating CA19-9 levels and tumor Immuno-histochemical (IHC) expression of CA19-9 [ Time Frame: Through study completion. Estimated at one year. ]
  • Assess relationship between circulating CA19-9 levels and MVT-5873 PK [ Time Frame: Through study completion. Estimated at one year. ]

Estimated Enrollment: 68
Study Start Date: January 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MVT-5873 Monotherapy Dose Escalation
Initial to maximum tolerated dose
Biological: MVT-5873
MVT-5873 is administered weekly by IV infusion. Dose will be increased during the study in order to define the MTD
Other Name: HuMab-5B1
Experimental: MVT-5873 Combination Dose Escalation
Escalating dose in combination with a standard of care chemotherapy
Biological: MVT-5873
MVT-5873 is administered weekly by IV infusion. Dose will be increased during the study in order to define the MTD
Other Name: HuMab-5B1

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672917


Contacts
Contact: Paul W Maffuid, PhD 858.259.9405 ext 305 clinicaltrials@mabvax.com

Locations
United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Erkut Borazanci, MD         
United States, Florida
Florida Cancer Specialist and Research Institute Recruiting
Sarasota, Florida, United States, 34233
Contact: Judy Wang, MD         
United States, New York
MSKCC Recruiting
New York, New York, United States, 10065
Contact: Eileen O'Reilly, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Todd Bauer, MD         
Sponsors and Collaborators
MabVax Therapeutics, Inc.
  More Information

Responsible Party: MabVax Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02672917     History of Changes
Other Study ID Numbers: MV-0715-CP-001.01
First Submitted: January 25, 2016
First Posted: February 3, 2016
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MabVax Therapeutics, Inc.:
CA19-9 Positive Malignancies

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases