Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
MV-0815-CP-001.01
- NCT ID:
NCT02687230
Conditions
- Pancreatic Carcinoma
- Tumors That Express CA19-9
Interventions
| Drug | Synonyms | Arms |
|---|
| MVT-2163 | 89Zr-DFO-HuMab-5B1 | Cohort 1 |
| MVT-5873 | HuMab-5B1 | Cohort 2 |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Cohort 1 | Experimental | Subjects receive 3 mg of MVT-2163 without the addition of prior MVT-5873. | |
| Cohort 2 | Experimental | Subjects receive 17 mg of MVT-5873 followed by 3 mg of MVT-2163. | |
| Cohort 3 | Experimental | Subjects receive 47 mg of MVT-5873 followed by 3 mg of MVT-2163. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety of MVT-2163 alone and in combination with MVT-5873 |
| Time Frame: | About 12 months |
| Safety Issue: | |
| Description: | Number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 will be collected and compiled |
Secondary Outcome Measures
| Measure: | The ability of MVT-2163 to detect sites of disease (localized and metastatic) in pancreatic cancer and/or other CA19-9 positive malignancies |
| Time Frame: | About 12 months |
| Safety Issue: | |
| 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 |
| Measure: | Radiation dosimetry estimates using quantitative MVT-2163 biodistribution uptake data |
| Time Frame: | About 12 months |
| Safety Issue: | |
| Description: | Bio-distribution data will be used to estimate the radiation exposure of key organs and tissues |
| Measure: | MVT-2163 PET imaging results in comparison with varying levels of CA19-9 antigen expression by IHC |
| Time Frame: | About 12 months |
| Safety Issue: | |
| 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 |
| Measure: | MVT-2163 PET imaging results in comparison with circulating CA19-9 levels |
| Time Frame: | About 12 months |
| Safety Issue: | |
| Description: | A determination will be made as to the effect of circulating levels of CA19-9 on the quality of MVT-2163 PET imaging |
| Measure: | Presence of anti-drug antibodies (ADA) using an MVT-5873 ADA assay |
| Time Frame: | About 12 months |
| Safety Issue: | |
| Description: | Subjects will be tested for the development of anti-drug antibodies (ADA) against MVT-5873 |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | BioNTech Research & Development, Inc. |
Last Updated
March 9, 2021
