- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02672917
Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Open label, multicenter, non-randomized, dose escalation/expansion trial of MVT-5873 as a single agent and in combination with standard of care chemotherapy or 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 as monotherapy (Group A), in combination with a standard of care chemotherapy (Group B), 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 (Groups E and F). 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 the respective 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.
Group A, B, and C are no longer open for enrollment.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: BioNTech clinical trials patient information
- Phone Number: +49 6131 9084
- Email: patients@biontech.de
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Recruiting
- HonorHealth Research Institute
-
Contact:
- Erkut Borazanci, MD
-
-
California
-
Los Angeles, California, United States, 90025
- Recruiting
- The Angeles Clinic & Research Institute
-
Contact:
- Vi Chiu, MD
-
-
Florida
-
Sarasota, Florida, United States, 34233
- Recruiting
- Florida Cancer Specialist and Research Institute
-
Contact:
- Judy Wang, MD
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- MSKCC
-
Contact:
- Eileen O'Reilly, MD
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Research Institute
-
Contact:
- Meredith Pelster, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria [all groups]
- 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 A, C, and Group D Dose Escalation]
- Evaluable or measurable disease based on RECISTv1.1
[Group A, 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 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 (based on institutional determination of CA19-9)
[Group E]
- Candidates for mFOLFIRINOX based on accepted standard of care
[Group F]
- Histologically or cytologically confirmed PDAC
- Macroscopically complete resection (R0 or R1 resection) performed between ≥21 and ≤84 days prior to C1D1
- Baseline scans without evidence of disease (e.g., CT/MRI)
- Full recovery from surgery and able to receive chemotherapy
- Free of significant nausea and vomiting
- No prior radiotherapy or chemotherapy
Exclusion Criteria [Groups A, B, C, D, and E]
- 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)
[Group F]
- Incomplete macroscopic tumor removal (R2 resection)
- Other known active cancer(s) likely to require treatment in the next 2 years
- Active, uncontrolled bacterial, viral, or fungal infection (s) requiring systemic therapy
- 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)
- Pre-existing neuropathy
- Known homozygous for UGT1A1*28 mutation
- Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
MVT-5873 monotherapy dose escalation, initial to maximum tolerated dose
|
intravenous infusion (IV)
Other Names:
|
Experimental: Group B
MVT-5873 is administered in Group B every 1 week in combination with gemcitabine and nab-paclitaxel
|
intravenous infusion (IV)
Other Names:
IV
|
Experimental: Group C
MVT-5873 is administered in Group C every 4 weeks by intravenous infusion following a lead in dose.
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.
|
intravenous infusion (IV)
Other Names:
|
Experimental: Group D
MVT-5873 is administered in Group D every 2 weeks by intravenous infusion following a lead in dose.
During dose escalation, doses of MVT-5873 will be increased to defined he MTD.
Up to 30 patients will be treated at the RP2D.
|
intravenous infusion (IV)
Other Names:
|
Experimental: Group E - metastatic
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.
|
intravenous infusion (IV)
Other Names:
IV
|
Experimental: Group F - adjuvant
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.
|
intravenous infusion (IV)
Other Names:
IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Group D - 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
|
Through study completion. Estimated at one year
|
Group D - Determine the MTD and/or RP2D of MVT-5873 on a Q2 week schedule
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
Group E - Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the metastatic disease setting
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
Group E - Determine the MTD and/or the RP2D of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the metastatic disease setting
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
Group F - Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the PDAC adjuvant setting
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
Group F - Determine the MTD and/or the RP2D of MVT-5873 administered in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the PDAC adjuvant setting
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group D - Evaluate the hepatic safety profile (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in participants without elevated circulating CA19-9 expression
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
|
All groups - 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.
|
Through study completion. Estimated at one year
|
All groups - Evaluate PK: Maximum concentration (Cmax) for MVT-5873
Time Frame: Through study completion. Estimated at one year
|
Determined using non-compartmental model.
|
Through study completion. Estimated at one year
|
All groups - Evaluate PK: Plasma half-life (T1/2) for MVT-5873
Time Frame: Through study completion. Estimated at one year
|
Determined using non-compartmental model.
|
Through study completion. Estimated at one year
|
Groups A, B, C, D, E - Evaluate tumor response rate
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
|
Groups A, B, C, D, E - Evaluate duration of response
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
|
Groups A, B, C, D, E - Evaluate time to response
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
|
Groups A, B, C, D, E - Evaluate progression free survival
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
|
All groups - Evaluate overall survival
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
|
Group F - Evaluate disease free survival
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
|
Group F - Evaluate time to recurrence
Time Frame: Through study completion. Estimated at one year
|
Through study completion. Estimated at one year
|
Collaborators and Investigators
Investigators
- Study Director: BioNTech Responsible Person, BioNTech SE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Folfirinox
- Gemcitabine
Other Study ID Numbers
- MV-0715-CP-001.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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