Study of a New Technique for Imaging Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04883775
• Other study ID #: 20-342
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 10, 2021
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

PART I : ESCALATION, EXPANSION, RE-ENTRY COHORTS:

• Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies

PART II: PRE-SURGERY COHORT ONLY:

• Patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3)

• Patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma OR

• Patients with Intraductal papillary mucinous neoplasm (IPMN) referred to surgery or biopsy as standard of care.

The suspicion for pancreatic carcinoma and decision for surgery or biopsy will be based on review of imaging and clinical findings in the disease management team discussion including surgeon and radiologist.

PART I and II:

• Signed, informed consent

• Age 18 or more years

• At least one lesion by CT or MRI = 2 cm, unless determine otherwise for pre-surgery cohort subjects

• CA19-9 serum level:

• For Part I: >ULN or CA19-9 positive biopsy (optional);

• For Part II ( presurgical cohort): CA19-9 serum level (normal or high levels are allowed) or CA19-9 positive biopsy (optional)

• ECOG performance status of 0 to 2

• Adequate laboratory parameters including:

• Absolute neutrophil count (ANC) =1.5 x 10^9/L

• Hemoglobin = 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)

• Platelet count >75,000/ mm^3

• 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

• Creatinine (serum or plasma) = 1.5 x ULN or eGFR>50 mL/min

PART I: ESCALATION, EXPANSION, RE-ENTRY COHORTS:

• Willingness to participate in collection of pharmacokinetic samples

Exclusion Criteria:

• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

• Major surgery other than diagnostic surgery within 4 weeks of Study Day 1

• History of anaphylactic reaction to human, or humanized, antibody

• Other on-going cancer therapy or investigational agents (except MVT-5873)

• Known history of HIV

• Pregnant or currently breast-feeding

• Psychiatric illness/social situations that would interfere with compliance with study requirements

• Prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol and be imaged up to 3 times)

Related Conditions & MeSH terms

• Pancreatic Cancer
• 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 will be administered intravenously over at least 60 minutes.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	BioNTech SE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with treatment-related adverse events as assessed	assessed by CTCAE v4.0	1 year
Primary	Biodistribution of MVT-2163	will be determined by measuring radiation exposure for key organs and tissues	1 year

External Links

•   Memorial Sloan Kettering Cancer Center