Clinical trial · Interventional
Study of a New Technique for Imaging Pancreatic Cancer
89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies
NCT04883775CI-TRIAL-00085297completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Tumors That Express CA19-9 | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MVT-2163 | Drug | MVT Regimen | ALIAS |
| MVT-5873 | Drug | MVT Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging
- 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.
- interventionNames
- Drug: MVT-2163
- Drug: MVT-5873
Primary outcomes (2)
- measure
- Number of subjects with treatment-related adverse events as assessed
- timeFrame
- 1 year
- description
- assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.