Recruiting
Early Phase 1

Pan800

Sponsor:

Eben Rosenthal

Code:

NCT07493447

Conditions

Meningioma

Glioblastoma

Acoustic Neuroma

Brain Cancer

Pituitary Adenoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Panitumumab-IRDye800

Study Details

Brief summary:

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.

Conditions

Meningioma

Glioblastoma

Acoustic Neuroma

Brain Cancer

Pituitary Adenoma

Study ID

NCT07493447

Start date

Jul, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Study Arm - 50 mg pan800

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.

experimental: Study Arm - 100 mg pan800

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.

Interventions

Panitumumab-IRDye800

Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion.

Primary outcome measure

  • Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions. [ Time Frame: From infusion to 15 days post-infusion. ]

Central Contacts and Locations

Central contacts

Makenna Brown

615-421-4370makenna.l.brown@vumc.org

Nicole Jones

615-936-2807nicole.l.jones@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232-0004

More Information

Sponsor

Eben Rosenthal

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Cancer
  • Malignant
  • Benign
  • Glioblastoma
  • Meningioma
  • Pituitary Adenoma
  • Acoustic Neuroma
  • Brain Masses
  • Intracranial Lesion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eben Rosenthal on 2026-06-30.