Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures

Eben Rosenthal

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Acoustic Neuroma; Glioblastoma; Meningioma; Pituitary Adenoma; Brain Cancer

Treatments: Drug: Panitumumab-IRDye800

Study type: Interventional

Funder types: Other

Identifiers

NCT07493447

VICCHN25072

Details and patient eligibility

About

This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.

Full description

This study will evaluate a single intravenous dose of panitumumab-IRDye800 (pan800) in subjects with intracranial lesions who are scheduled to undergo standard-of-care neurosurgical resection. The study drug will be administered 1-5 days prior to surgery, after which participants will undergo their planned procedure with intraoperative near-infrared fluorescence imaging to assess tumor visualization. Following the infusion, subjects will be monitored for immediate adverse events, and a member of the study team will continue safety follow-up through postoperative assessments and a Day 15 follow-up contact. Participants will otherwise continue to receive standard-of-care evaluation and treatment for their intracranial disease at the discretion of their treating physicians.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.

• Subject age ≥ 18 years.

• Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:

  1. Chemistry Panel - Potassium, BUN (or urea), and Creatinine
  2. CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
  3. Magnesium and Phosphorus

• Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration.

• Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.

Exclusion criteria

• Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.
• History of infusion reactions to any monoclonal antibody therapies.
• Women who are currently pregnant or breastfeeding.
• Participants presenting with a baseline QTcF interval > than 480 milliseconds.
• Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.
• Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
• Patients with severe renal disease or anuria

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Study Arm - 50 mg pan800

Experimental group

Description:

Participants will receive a single 50 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring, postoperative pharmacokinetic blood draws, and adverse-event assessments through surgery and a Day 15 (±7) follow-up.

Treatment:

Drug: Panitumumab-IRDye800

Study Arm - 100 mg pan800

Experimental group

Description:

Participants will receive a single 100 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before their standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring along with postoperative pharmacokinetic and immunogenicity blood sampling and adverse-event assessments through surgery and the Day 15 (±7) follow-up visit.

Treatment:

Drug: Panitumumab-IRDye800