Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach brain tumors so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinical diagnosis of presumed high-grade glioma, based on image data.
• Tumor judged to be suitable and planned for open cranial resection.
• Valid informed consent by participant.
• Age ≥ 18 years old.
• Ability to understand and the willingness to sign a written informed consent document.
Locations
United States
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Contact Information
Primary
Keith D Paulsen, PhD
keith.d.paulsen@dartmouth.edu
603-646-2695
Backup
Linton Evans, MD
Time Frame
Start Date: 2026-02-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 33
Treatments
Experimental: ABY-029 6X dose group
ABY-029 will be administered at the 6X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
Experimental: ABY-029 10X dose group
ABY-029 will be administered at the 10X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Dartmouth College, National Cancer Institute (NCI)
Leads: Dartmouth-Hitchcock Medical Center