Clinical trial NCT04883775: Study of a New Technique for Imaging Pancreatic Cancer
Official title: 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Tumors That Express CA19-9
Keywords: 89Zr-DFO-HuMab-5B1 (MVT-2163)
Imaging
MVT-5873
20-342
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: BioNTech SE
First posted: 2021-05-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a phase I, open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 (89Zr-DFO-HuMab-5B1) and varying antibody masses of MVT-5873 (HuMab-5B1), designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging. This trial will include dose escalation, which includes up to 5 cohorts, an expansion phase, a re-entry phase, and a pre-surgery phase.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of subjects with treatment-related adverse events as assessed
timeFrame: 1 year
measure: Biodistribution of MVT-2163
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neeta Pandit-Taskar, MD
role: PRINCIPAL_INVESTIGATOR
References: