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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

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ClinicalTrials.gov Identifier: NCT02672917
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
BioNTech SE ( BioNTech Research & Development, Inc. )

Brief Summary:
Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: MVT-5873 Drug: modified FOLFIRINOX (mFOLFIRINOX) Phase 1

Detailed Description:

Open label, multicenter, non-randomized, dose escalation/expansion trial of MVT-5873 as a single agent and in combination with modified FOLFIRINOX (mFOLFIRINOX) in subjects with pancreatic and other CA19-9 positive malignancies. The study will define a Maximum Tolerated Dose (MTD) of MVT-5873 for a Q2 week schedule (Group D), an MTD of MVT-5873 for a Q4 week schedule (Group C), and an MTD for a Q2 week schedule of MVT-5873 in combination with mFOLFIRINOX (Group E). Each group will utilize a conventional 3+3 study design to identify the MTD and recommended phase 2 dose (RP2D).

Following the definition of an MTD in each group, the RP2D of MVT-5873 as a single agent and in combination with mFOLFIRINOX will be defined. Following the completion of the dose escalation phase for each group, an expansion group of up to 30 additional subjects will be treated at the RP2D for each group. In Group D, subjects will be subdivided into two groups of up to 15 subjects: subjects without peripheral blood expression of CA19-9 and subjects with peripheral blood expression of CA19-9. MVT-5873 pharmacokinetics (PK) and pharmacodynamics (PD) will be determined in each group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 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 : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group C
MVT-5873 is administered in Group C every 4 weeks by intravenous infusion. Each cycle is 28 days. During dose escalation, doses of MVT-5873 will be increased to define the MTD. Up to 30 patients will be treated at the RP2D.
Drug: MVT-5873
intravenous infusion (IV)
Other Name: HuMab-5B1

Experimental: Group D
MVT-5873 is administered in Group D every 2 weeks by intravenous infusion. During dose escalation, doses of MVT-5873 will be increased to defined he MTD. Up to 30 patients will be treated at the RP2D.
Drug: MVT-5873
intravenous infusion (IV)
Other Name: HuMab-5B1

Experimental: Group E
MVT-5873 is administered in combination with mFOLFIRINOX every 2 weeks. Both MVT-5873 and mFOLFIRINOX will be administered by intravenous infusion. During dose escalation, doses of MVT-5873, will be increased to define the MTD in combination with mFOLFIRINOX. mFOLFIRINOX will be administered according to institutional standards in compliance with the package insert for each drug. Up to 30 patients will be treated at the RP2D.
Drug: MVT-5873
intravenous infusion (IV)
Other Name: HuMab-5B1

Drug: modified FOLFIRINOX (mFOLFIRINOX)
IV




Primary Outcome Measures :
  1. Determine the safety (treatment related adverse events as assessed by Common Toxicity Criteria for Adverse Events [CTCAE] V5.0) of MVT-5873 on a Q2 week schedule [ Time Frame: Through study completion. Estimated at one year ]
  2. Determine the MTD and/or RP2D of MVT-5873 on a Q2 week schedule [ Time Frame: Through study completion. Estimated at one year ]
  3. Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 on a Q4 week schedule [ Time Frame: Through study completion. Estimated at one year ]
  4. Determine the MTD and/or RP2D of MVT-5873 on a Q4 week schedule [ Time Frame: Through study completion. Estimated at one year ]
  5. Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) [ Time Frame: Through study completion. Estimated at one year ]
  6. Determine the MTD and/or the RP2D of MVT-5873 administered in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) [ Time Frame: Through study completion. Estimated at one year ]

Secondary Outcome Measures :
  1. Evaluate the safety profile (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in subjects without circulating CA19-9 expression [ Time Frame: Through study completion. Estimated at one year ]
  2. Evaluate pharmacokinetics (PK): Area Under the Curve (AUC) for MVT-5873 [ Time Frame: Through study completion. Estimated at one year ]
    Determined using non-compartmental model.

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

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

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


Information from the National Library of Medicine

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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 or cytologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
  • 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

[Group C and Group D Dose Escalation]

  • Evaluable or measurable disease based on RECISTv1.1
  • Serum CA19-9 levels ≤ 4000 U/mL

[Group C and D]

  • Progression following treatment with standard of care for the subject's specific tumor type

[Group C and D Expansion and Group E Escalation and Expansion]

  • Measurable disease based on RECISTv1.1

[Group C and D Expansion, non-PDAC malignancies]

  • If negative serum CA19-9 levels (defined as < 1 U/mL or below the level of detection for institutional test used), subject must have confirmation of CA19-9 expression in their tumor prior to study entry

[Group E]

  • Candidates for mFOLFIRINOX based on accepted standard of care

Exclusion Criteria

  • Brain metastases unless previously treated and well controlled for at least 3 months prior to study day 1
  • 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 (or 5 half-lives for systemic agents, whichever is shorter) from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation (except for ongoing hormonal therapy for prostate cancer)
  • Major surgery within 28 days of Study Day 1
  • History of anaphylactic reaction to human, or humanized, antibody
  • Pregnant or currently breast-feeding
  • Known HIV, Hepatitis B or C-positive
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, 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: BioNTech clinical trials patient information +49 6131 9084 ext 1919 patients@biontech.de
Contact: BioNTech clinical trial information desk +49 6131 9084 ext 0 info@biontech.de

Locations
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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
BioNTech Research & Development, Inc.
Investigators
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Study Director: BioNTech Responsible Person BioNTech SE
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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: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by BioNTech SE ( BioNTech Research & Development, Inc. ):
CA19-9 Positive Malignancies
Pancreatic Cancer and other CA19-9 expressing malignancies
Pancreatic Ductal Adenocarcinoma (PDAC)
Sialyl Lewis A (sLea)
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
Folfirinox
Antineoplastic Agents