Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures

This phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 and to see how well it works in finding cancer in patients with pancreatic cancer who are undergoing surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with pancreatic cancer.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Biological: Panitumumab; Drug: Panitumumab-IRDye800; Procedure: Fluorescence Imaging

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the optimal dose of panitumumab-IRDye800 in identifying pancreatic cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of the panitumumab-IRDye800 as an imaging agent in subjects undergoing resection of pancreatic cancer.

II. Determine whether metastatic lesions, positive lymph node, or residual disease can be detected by near-infrared (NIR) fluorescence imaging with panitumumab-IRDye800 but not by white light.

OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.

Patients receive a loading dose of panitumumab intravenously (IV) over 60 minutes, and after 15 minutes of observation, patients then receive panitumumab-IRDye800 IV over 60 minutes on day 0. Patients then undergo surgical resection 2-5 days after panitumumab-IRDye800 administration with imaging using the Novadaq SPY/LUNA, Novadaq IR9000 fluorescence imaging system with open field handheld fluorescence imaging camera, and/or pinpoint endoscopic fluorescence imaging camera, and SurgVision Explorer Air multi spectral fluorescence reflectance system.

After completion of study treatment, patients are followed up at 15 and 30 days.

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu; Phone Number: (650) 498-7757; Email: gitrialeligibility@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University, School of Medicine
      • Principal Investigator: George Poultsides
      • Contact: Email: gitrialeligibility@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma
• Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
• Life expectancy of more than 12 weeks
• Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level =< 1
• Hemoglobin >= 9 gm/dL
• Platelet count >= 100,000/mm^3
• Magnesium > the lower limit of normal per institution normal lab values
• Potassium > the lower limit of normal per institution normal lab values
• Calcium > the lower limit of normal per institution normal lab values
• Thyroid-stimulating hormone (TSH) < 13 micro international units/mL

Exclusion Criteria:

• Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
• Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment
• History of infusion reactions to panitumumab or other monoclonal antibody therapies
• Pregnant or breastfeeding
• Evidence of corrected QT (QTc) prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 460 ms in females)
• Lab values that in the opinion of the physician would prevent surgical resection
• Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1a; A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. Cohort 1a will receive 25 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices	Biological: Panitumumab; Given IV; Other Names: ABX-EGF; ABX-EGF Monoclonal Antibody; ABX-EGF, Clone E7.6.3; MoAb ABX-EGF; Monoclonal Antibody ABX-EGF; Vectibix; Drug: Panitumumab-IRDye800; Given IV; Other Names: Panitumumab IRDye 800; RDye800-Panitumumab Conjugate; Procedure: Fluorescence Imaging; Undergo fluorescence imaging
Experimental: Cohort 1b; Cohort 1b will receive 50 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices	Biological: Panitumumab; Given IV; Other Names: ABX-EGF; ABX-EGF Monoclonal Antibody; ABX-EGF, Clone E7.6.3; MoAb ABX-EGF; Monoclonal Antibody ABX-EGF; Vectibix; Drug: Panitumumab-IRDye800; Given IV; Other Names: Panitumumab IRDye 800; RDye800-Panitumumab Conjugate; Procedure: Fluorescence Imaging; Undergo fluorescence imaging
Experimental: Cohort 1c; Cohort 1c will receive 75 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab.A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices	Biological: Panitumumab; Given IV; Other Names: ABX-EGF; ABX-EGF Monoclonal Antibody; ABX-EGF, Clone E7.6.3; MoAb ABX-EGF; Monoclonal Antibody ABX-EGF; Vectibix; Drug: Panitumumab-IRDye800; Given IV; Other Names: Panitumumab IRDye 800; RDye800-Panitumumab Conjugate; Procedure: Fluorescence Imaging; Undergo fluorescence imaging
Experimental: Cohort 1d; Cohort 1d will receive a 50 mg dose of Panitumumab IRDye800 and no test/loading dose. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices	Biological: Panitumumab; Given IV; Other Names: ABX-EGF; ABX-EGF Monoclonal Antibody; ABX-EGF, Clone E7.6.3; MoAb ABX-EGF; Monoclonal Antibody ABX-EGF; Vectibix; Drug: Panitumumab-IRDye800; Given IV; Other Names: Panitumumab IRDye 800; RDye800-Panitumumab Conjugate; Procedure: Fluorescence Imaging; Undergo fluorescence imaging
Experimental: Cohort 2- Dose Expansion; Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1	Biological: Panitumumab; Given IV; Other Names: ABX-EGF; ABX-EGF Monoclonal Antibody; ABX-EGF, Clone E7.6.3; MoAb ABX-EGF; Monoclonal Antibody ABX-EGF; Vectibix; Drug: Panitumumab-IRDye800; Given IV; Other Names: Panitumumab IRDye 800; RDye800-Panitumumab Conjugate; Procedure: Fluorescence Imaging; Undergo fluorescence imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor to background ratio (TBR)	TBR is defined as fluorescence intensity of tumor tissue compared to that of normal surrounding pancreatic tissue.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug	Safety events will be recorded over the 30 day observation period.	Up to 30 days
Number of positive lymph nodes per participant, not detected by white light	Determine whether positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light.	1 day
Number of positive resection margins per participant, not detected by white light	Determine whether residual disease at resection margins can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light.	1 day

Collaborators and Investigators

• Sponsor: George Poultsides
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: George Poultsides, Stanford University

Publications and helpful links

General Publications

• Lu G, van den Berg NS, Martin BA, Nishio N, Hart ZP, van Keulen S, Fakurnejad S, Chirita SU, Raymundo RC, Yi G, Zhou Q, Fisher GA, Rosenthal EL, Poultsides GA. Tumour-specific fluorescence-guided surgery for pancreatic cancer using panitumumab-IRDye800CW: a phase 1 single-centre, open-label, single-arm, dose-escalation study. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):753-764. doi: 10.1016/S2468-1253(20)30088-1. Epub 2020 May 14.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 23, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Amino Acids, Peptides, and Proteins; Proteins; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Diagnostic Imaging; Panitumumab; Optical Imaging
• Other Study ID Numbers: IRB-42237; R01CA190306 (U.S. NIH Grant/Contract); NCI-2017-01943 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); PANC0028 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No