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

Pancreatic Carcinoma Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT02687230
• Other study ID #: MV-0815-CP-001.01
• Status: Terminated
• Phase: Phase 1
• Start date: July 11, 2016
• Est. completion date: May 5, 2017

Study information

• Verified date: August 2021
• Source: BioNTech SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Tumors That Express CA19-9

Intervention

Drug:
• MVT-2163
MVT-2163 is administered intravenously as a PET imaging agent
• MVT-5873
MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-2163

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
BioNTech Research & Development, Inc.	SciQuus Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Peak Plasma Concentration (Cmax) of MVT-2163 alone and in combination with MVT-5873	Cmax of MVT-2163	About 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	About 12 months
Secondary	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	About 12 months
Secondary	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	About 12 months
Secondary	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	About 12 months
Secondary	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	About 12 months