Study Stopped
Sponsor decision
Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1
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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedStudy Start
First participant enrolled
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2017
CompletedAugust 31, 2021
August 1, 2021
10 months
February 9, 2016
August 26, 2021
Conditions
Outcome Measures
Primary Outcomes (7)
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
About 12 months
Peak Plasma Concentration (Cmax) of MVT-2163 alone and in combination with MVT-5873
Cmax of MVT-2163
About 12 months
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
About 12 months
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
About 12 months
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
About 12 months
Area under the plasma concentration versus time curve (AUC) of MVT-2163 alone and in combination with MVT-5873
AUC of MVT-2163
About 12 months
Half-life (T1/2) of MVT-2163 alone and in combination with MVT-5873
Half-life (T1/2) of MVT-2163
About 12 months
Secondary Outcomes (5)
The ability of MVT-2163 to detect sites of disease (localized and metastatic) in pancreatic cancer and/or other CA19-9 positive malignancies
About 12 months
Radiation dosimetry estimates using quantitative MVT-2163 biodistribution uptake data
About 12 months
MVT-2163 PET imaging results in comparison with varying levels of CA19-9 antigen expression by IHC
About 12 months
MVT-2163 PET imaging results in comparison with circulating CA19-9 levels
About 12 months
Presence of anti-drug antibodies (ADA) using an MVT-5873 ADA assay
About 12 months
Study Arms (3)
Cohort 1
EXPERIMENTALSubjects receive 3 mg of MVT-2163 without the addition of prior MVT-5873.
Cohort 2
EXPERIMENTALSubjects receive 17 mg of MVT-5873 followed by 3 mg of MVT-2163.
Cohort 3
EXPERIMENTALSubjects receive 47 mg of MVT-5873 followed by 3 mg of MVT-2163.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech Research & Development, Inc.lead
- SciQuus Oncologycollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
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.
PMID: 35046060DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BioNTech Responsible Person
BioNTech SE
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2016
First Posted
February 22, 2016
Study Start
July 11, 2016
Primary Completion
May 5, 2017
Study Completion
May 5, 2017
Last Updated
August 31, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share