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Trial record 1 of 1 for:    02672917
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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

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.
 
ClinicalTrials.gov Identifier: NCT02672917
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
BioNTech Research & Development, Inc. (New Sponsor)
Information provided by (Responsible Party):
MabVax Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date November 14, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02672917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2016)
  • 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. ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
Official Title  ICMJE 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
Brief Summary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: MVT-5873 Monotherapy Dose Escalation
    Initial to maximum tolerated dose
    Intervention: Biological: MVT-5873
  • Experimental: MVT-5873 Combination Dose Escalation
    Escalating dose in combination with a standard of care chemotherapy
    Intervention: Biological: MVT-5873
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
68
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2016)
62
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandra Kemmer-Brueck alexandra.kemmer-brueck@biontech.de
Contact: Stefanie Bolte, PhD stefanie.bolte@biontech.de
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672917
Other Study ID Numbers  ICMJE MV-0715-CP-001.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MabVax Therapeutics, Inc.
Study Sponsor  ICMJE MabVax Therapeutics, Inc.
Collaborators  ICMJE BioNTech Research & Development, Inc. (New Sponsor)
Investigators  ICMJE Not Provided
PRS Account MabVax Therapeutics, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP