Study of a New Technique for Imaging Pancreatic Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Tumors That Express CA19-9; Pancreatic Cancer

Treatments: Drug: MVT-2163; Drug: MVT-5873

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04883775

20-342

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging

Experimental group

Description:

All subjects will receive a single, fixed, intravenous dose of MVT-2163, consisting of 3 mg (nominal mass - actual mass administered will likely vary between 2.0 and 2.5 mg) of MVT-2163 radiolabeled from 5 mCi to no less than 1.0 mCi (adjusted as of 16-Mar 2017) of 89Zr.Cohort 1 subjects will receive MVT-2163, with no MVT-5873 pre-dosing. Subjects in subsequent cohorts 2 and 3 will receive a dose of MVT-5873 15 minutes, \~ 2 hours, and \~4 hours prior to administration of MVT-2163. Future cohorts 4 and 5 may evaluate alternate time frames. Other cohorts may evaluate administration of MVT-5873 one week prior (D-7) to the day of MVT-2163 administration and a second administration of MVT-5873 the day of (D0) MVT-2163 administration. The re-entry (RE) and pre-surgery (PS) cohorts will administer MVT-2163 3 ± 1 hour after administration of MVT-5873.

Treatment:

Drug: MVT-5873

Drug: MVT-2163