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Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1

Primary Purpose

Pancreatic Carcinoma, Tumors That Express CA19-9

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MVT-2163
MVT-5873
Sponsored by
BioNTech Research & Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed, informed consent
  • Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
  • At least one lesion by CT or MRI ≥ 2 cm
  • ECOG performance status of 0 to 2
  • Absolute neutrophil count ≥1.50 x 109/L
  • Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
  • Platelet count >75,000/ mm3
  • AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN
  • Total bilirubin <1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, <3x the upper limit of normal
  • Serum creatinine (serum or plasma) ≤ 1.5 x ULN or GFR>50 mL/min
  • Serum albumin > 3.0g/dL
  • Willingness to participate in collection of pharmacokinetic samples
  • Willingness to use adequate contraception throughout study and for a period of 90 days last dose of study drug

Exclusion Criteria:

  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Major surgery other than diagnostic surgery within 28 days
  • History of anaphylactic reaction to human, or humanized, antibody
  • Other on-going cancer therapy or investigational agents (except MVT-5873 )
  • Known history of HIV or Hepatitis C
  • Pregnant or currently breast-feeding
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Significant cardiovascular risk including, but not limited to, recent (within 28 days) coronary stenting or myocardial infarction within 6 months

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Subjects receive 3 mg of MVT-2163 without the addition of prior MVT-5873.

Subjects receive 17 mg of MVT-5873 followed by 3 mg of MVT-2163.

Subjects receive 47 mg of MVT-5873 followed by 3 mg of MVT-2163.

Outcomes

Primary Outcome Measures

Safety of MVT-2163 alone and in combination with MVT-5873
Number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 will be collected and compiled
Peak Plasma Concentration (Cmax) of MVT-2163 alone and in combination with MVT-5873
Cmax of MVT-2163
Biodistribution of MVT-2163 alone and in combination with MVT-5873
The biodistribution of MVT-2163 will be determined by measuring radiation exposure for key organs and tissues
Dose of MVT-5873 required for optimal tumor visualization when combined with a fixed dose of MVT-2163
Three doses of MVT-5873 (0, 17, and 47 mg) will be combined with MVT-2163 in order to determine which dose results in the best PET imaging of tumor
Determine the optimal time interval between MVT-2163 dose administration and tumor PET imaging
Images will be taken on several days over the first week to determine the optimal day for obtaining PET images
Area under the plasma concentration versus time curve (AUC) of MVT-2163 alone and in combination with MVT-5873
AUC of MVT-2163
Half-life (T1/2) of MVT-2163 alone and in combination with MVT-5873
Half-life (T1/2) of MVT-2163

Secondary Outcome Measures

The ability of MVT-2163 to detect sites of disease (localized and metastatic) in pancreatic cancer and/or other CA19-9 positive malignancies
PET scans obtained with MVT-2163 will be compared with conventional imaging (CT/MRI) to determine if MVT-2163 based PET scans are capable of detection tumors seen with conventional methods
Radiation dosimetry estimates using quantitative MVT-2163 biodistribution uptake data
Bio-distribution data will be used to estimate the radiation exposure of key organs and tissues
MVT-2163 PET imaging results in comparison with varying levels of CA19-9 antigen expression by IHC
A determination will be made as to the effect of varying levels of CA19-9 antigen expression by tumor IHC on the quality of MVT-2163 PET imaging
MVT-2163 PET imaging results in comparison with circulating CA19-9 levels
A determination will be made as to the effect of circulating levels of CA19-9 on the quality of MVT-2163 PET imaging
Presence of anti-drug antibodies (ADA) using an MVT-5873 ADA assay
Subjects will be tested for the development of anti-drug antibodies (ADA) against MVT-5873

Full Information

First Posted
February 9, 2016
Last Updated
August 26, 2021
Sponsor
BioNTech Research & Development, Inc.
Collaborators
SciQuus Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT02687230
Brief Title
Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1
Official Title
Phase 1 Study of 89Zr-DFO-HuMab-5B1 (MVT-2163) With HuMab-5B1 (MVT-5873) in Patients With Pancreatic Cancer or Other CA19-9 Positive Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
July 11, 2016 (Actual)
Primary Completion Date
May 5, 2017 (Actual)
Study Completion Date
May 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNTech Research & Development, Inc.
Collaborators
SciQuus Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for imaging and a clinical assessment. The last study visit is on day 28.
Detailed Description
This is an open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 and varying antibody masses of MVT-5873. The study is designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging using PET scanning. This trial will include a dose escalation and an expansion phase. During the dose escalation portion of the study, a determination of the optimal time to perform PET imaging will be made. Following the identification of the "optimal" dose and timing, an 10 additional subjects will be imaged using the best dose and timing. In each portion of the study subjects will have a screening visit and, no more than 28 days later, those who are eligible for the study will receive MVT-2163. Each cohort will have 3-6 subjects. Subjects in cohort 1 will be administered MVT-2163 alone on day 1. Subjects in cohorts 2 and 3 will receive MVT-5873 on day 1, followed approximately 10 minutes later by MVT-2163. Subjects will return for visits to the clinic on days 2, 4, and 7 for additional imaging and safety assessments. A follow-up visit will occur on day 28. The study will also evaluate the tissue distribution and pharmacokinetics of MVT-2163 and, based on these data, the study will estimate the radiation dosimetry of MVT-2163. Safety assessments will be performed using ECGs, vital signs measurements, assessments of performance status, and clinical laboratory measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma, Tumors That Express CA19-9

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects receive 3 mg of MVT-2163 without the addition of prior MVT-5873.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects receive 17 mg of MVT-5873 followed by 3 mg of MVT-2163.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Subjects receive 47 mg of MVT-5873 followed by 3 mg of MVT-2163.
Intervention Type
Drug
Intervention Name(s)
MVT-2163
Other Intervention Name(s)
89Zr-DFO-HuMab-5B1
Intervention Description
MVT-2163 is administered intravenously as a PET imaging agent
Intervention Type
Drug
Intervention Name(s)
MVT-5873
Other Intervention Name(s)
HuMab-5B1
Intervention Description
MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-2163
Primary Outcome Measure Information:
Title
Safety of MVT-2163 alone and in combination with MVT-5873
Description
Number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 will be collected and compiled
Time Frame
About 12 months
Title
Peak Plasma Concentration (Cmax) of MVT-2163 alone and in combination with MVT-5873
Description
Cmax of MVT-2163
Time Frame
About 12 months
Title
Biodistribution of MVT-2163 alone and in combination with MVT-5873
Description
The biodistribution of MVT-2163 will be determined by measuring radiation exposure for key organs and tissues
Time Frame
About 12 months
Title
Dose of MVT-5873 required for optimal tumor visualization when combined with a fixed dose of MVT-2163
Description
Three doses of MVT-5873 (0, 17, and 47 mg) will be combined with MVT-2163 in order to determine which dose results in the best PET imaging of tumor
Time Frame
About 12 months
Title
Determine the optimal time interval between MVT-2163 dose administration and tumor PET imaging
Description
Images will be taken on several days over the first week to determine the optimal day for obtaining PET images
Time Frame
About 12 months
Title
Area under the plasma concentration versus time curve (AUC) of MVT-2163 alone and in combination with MVT-5873
Description
AUC of MVT-2163
Time Frame
About 12 months
Title
Half-life (T1/2) of MVT-2163 alone and in combination with MVT-5873
Description
Half-life (T1/2) of MVT-2163
Time Frame
About 12 months
Secondary Outcome Measure Information:
Title
The ability of MVT-2163 to detect sites of disease (localized and metastatic) in pancreatic cancer and/or other CA19-9 positive malignancies
Description
PET scans obtained with MVT-2163 will be compared with conventional imaging (CT/MRI) to determine if MVT-2163 based PET scans are capable of detection tumors seen with conventional methods
Time Frame
About 12 months
Title
Radiation dosimetry estimates using quantitative MVT-2163 biodistribution uptake data
Description
Bio-distribution data will be used to estimate the radiation exposure of key organs and tissues
Time Frame
About 12 months
Title
MVT-2163 PET imaging results in comparison with varying levels of CA19-9 antigen expression by IHC
Description
A determination will be made as to the effect of varying levels of CA19-9 antigen expression by tumor IHC on the quality of MVT-2163 PET imaging
Time Frame
About 12 months
Title
MVT-2163 PET imaging results in comparison with circulating CA19-9 levels
Description
A determination will be made as to the effect of circulating levels of CA19-9 on the quality of MVT-2163 PET imaging
Time Frame
About 12 months
Title
Presence of anti-drug antibodies (ADA) using an MVT-5873 ADA assay
Description
Subjects will be tested for the development of anti-drug antibodies (ADA) against MVT-5873
Time Frame
About 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed, informed consent Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies At least one lesion by CT or MRI ≥ 2 cm ECOG performance status of 0 to 2 Absolute neutrophil count ≥1.50 x 109/L Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days) Platelet count >75,000/ mm3 AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN Total bilirubin <1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, <3x the upper limit of normal Serum creatinine (serum or plasma) ≤ 1.5 x ULN or GFR>50 mL/min Serum albumin > 3.0g/dL Willingness to participate in collection of pharmacokinetic samples Willingness to use adequate contraception throughout study and for a period of 90 days last dose of study drug Exclusion Criteria: Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy Major surgery other than diagnostic surgery within 28 days History of anaphylactic reaction to human, or humanized, antibody Other on-going cancer therapy or investigational agents (except MVT-5873 ) Known history of HIV or Hepatitis C Pregnant or currently breast-feeding Psychiatric illness/social situations that would interfere with compliance with study requirements Significant cardiovascular risk including, but not limited to, recent (within 28 days) coronary stenting or myocardial infarction within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BioNTech Responsible Person
Organizational Affiliation
BioNTech SE
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35046060
Citation
Tully KM, Tendler S, Carter LM, Sharma SK, Samuels ZV, Mandleywala K, Korsen JA, Delos Reyes AM, Piersigilli A, Travis WD, Sen T, Pillarsetty N, Poirier JT, Rudin CM, Lewis JS. Radioimmunotherapy Targeting Delta-like Ligand 3 in Small Cell Lung Cancer Exhibits Antitumor Efficacy with Low Toxicity. Clin Cancer Res. 2022 Apr 1;28(7):1391-1401. doi: 10.1158/1078-0432.CCR-21-1533.
Results Reference
derived

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Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1

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