Clinical Trials /

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

NCT02672917

Description:

Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Related Conditions:
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: MV-0715-CP-001.01
  • NCT ID: NCT02672917

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
MVT-5873HuMab-5B1MVT-5873 Monotherapy Dose Escalation

Purpose

Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

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.
    

Trial Arms

NameTypeDescriptionInterventions
MVT-5873 Monotherapy Dose EscalationExperimentalInitial to maximum tolerated dose
    MVT-5873 Combination Dose EscalationExperimentalEscalating dose in combination with a standard of care chemotherapy

      Eligibility 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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Determine the maximum tolerated dose (MTD) of MVT-5873 as a single agent
      Time Frame:Through study completion. Estimated at one year
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Assess Response Rate
      Time Frame:Through study completion. Estimated at one year
      Safety Issue:
      Description:
      Measure:Assess Duration of Response
      Time Frame:Through study completion. Estimated at one year
      Safety Issue:
      Description:
      Measure:Determine the adverse event rate for MVT-5873
      Time Frame:Through study completion. Estimated at one year
      Safety Issue:
      Description:Number of participants with treatment-related adverse events as assessed by CTCAE v4
      Measure:Determine pharmacokinetics (PK): Area Under the Curve (AUC) for MVT-5873
      Time Frame:Through study completion. Estimated at one year.
      Safety Issue:
      Description:Determined using non-compartmental model.
      Measure:Determine PK: Maximum concentration (Cmax) for MVT-5873
      Time Frame:Through study completion. Estimated at one year.
      Safety Issue:
      Description:Determined using non-compartmental model.
      Measure:Determine PK: Plasma half-life (T1/2) for MVT-5873
      Time Frame:Through study completion. Estimated at one year.
      Safety Issue:
      Description:Determined using non-compartmental model.

      Details

      Phase:Phase 1
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:MabVax Therapeutics, Inc.

      Trial Keywords

      • CA19-9 Positive Malignancies

      Last Updated

      December 23, 2016