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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 : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
BioNTech SE ( BioNTech Research & Development, Inc. )

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: MVT-5873 Phase 1

Detailed Description:
Open label, multi-center, nonrandomized, dose escalation/expansion trial of MVT-5873 as a single agent in subjects with pancreatic and other CA19-9 positive malignancies. The trial will define a Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of MVT-5873 for a Q2 week schedule (Group D) and an MTD and RP2D of MVT-5873 for a Q4 week schedule (Group C). Both groups will utilize a conventional 3+3 study design to identify the MTD and RP2D. Following completion of the dose escalation phase, an expansion phase of up to 30 additional subjects will be administered MVT-5873 at the RP2D for each group. The pharmacokinetics (PK) of MVT-5873 will be determined in each Group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) With Expansion in Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MVT-5873 Dose Escalation
Initial to maximum tolerated dose (MTD)
Biological: MVT-5873
MVT-5873 is administered in Group D every 2 weeks and in Group C every 4 weeks by IV infusion. Dose will be increased during the study in order to define the MTD
Other Name: HuMab-5B1




Primary Outcome Measures :
  1. Determine the safety and maximum tolerated dose (MTD) and/or the RP2D of MVT-5873 as a single agent [ Time Frame: Through study completion. Estimated at one year ]

Secondary Outcome Measures :
  1. 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.

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

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

  4. Assess tumor response rate [ Time Frame: Through study completion. Estimated at one year ]
  5. Assess duration of response [ Time Frame: Through study completion. Estimated at one year ]
  6. Assess time to response [ Time Frame: Through study completion. Estimated at one year ]
  7. Assess progression free survival [ Time Frame: Through study completion. Estimated at one year ]
  8. Assess overall survival [ Time Frame: Through study completion. Estimated at one year ]

Other Outcome Measures:
  1. Assess anti-MVT-5873 antibodies [ Time Frame: Through study completion. Estimated at one year ]
  2. Assess circulating immune complexes (CIC) [ Time Frame: Through study completion. Estimated at one year ]
  3. Assess the relationship between circulating CA19-9 levels and response and toxicity [ Time Frame: Through study completion. Estimated at one year ]
  4. Assess the relationship between tumor immunohistochemistry (IHC) expression and circulating levels of CA19-9 [ Time Frame: Through study completion. Estimated at one year ]
  5. Assess the relationship between circulating CA19-9 levels and MVT-5873 PK [ Time Frame: Through study completion. Estimated at one year ]
  6. [Optional] Assess the relationship between potential genetic biomarkers and response and toxicity [ Time Frame: Through study completion. Estimated at one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria

  • Signed, informed consent
  • Age 18 or more years
  • Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
  • Evaluable or measurable disease based on RECISTv1.1
  • Recovered from prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with approval of the Medical Monitor
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100% to 80%
  • Adequate hematologic, hepatic, and renal function
  • Willingness to participate in collection of pharmacokinetic samples
  • Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of MVT-5873
  • Progression following treatment with standard of care for the subject's specific tumor type

Exclusion Criteria

  • Brain metastases unless previously treated and well controlled for at least 3 months
  • Other known active cancer(s) likely to require treatment in the next two (2) years
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • 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.
  • Major surgery other than diagnostic surgery within 28 days of Study Day 1
  • History of anaphylactic reaction to human, or humanized, antibody
  • Pregnant or currently breast-feeding
  • Known HIV-positive or Hepatitis C
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Significant cardiovascular risk including, but not limited to, recent (within 4 weeks) coronary stenting or myocardial infarction within 6 months

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
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Contact: Alexandra Kemmer-Brueck alexandra.kemmer-brueck@biontech.de
Contact: Stefanie Bolte, PhD stefanie.bolte@biontech.de

Locations
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United States, Arizona
HonorHealth Research Institute Active, not recruiting
Scottsdale, Arizona, United States, 85258
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
BioNTech Research & Development, Inc.
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Responsible Party: BioNTech Research & Development, Inc.
ClinicalTrials.gov Identifier: NCT02672917    
Other Study ID Numbers: MV-0715-CP-001.01
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BioNTech SE ( BioNTech Research & Development, Inc. ):
CA19-9 Positive Malignancies
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases