ABY-029 to highlight gliomas during surgery
Official title: Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma
Run by Dartmouth-Hitchcock Medical Center · NCT07063693 · Data updated 2026-11-12
This will test whether tiny doses of ABY-029 help surgeons see glioma tumors better during open brain surgery in adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Status | Recruiting |
| Started | February 17, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07063693 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with a clinical diagnosis of presumed high-grade glioma who are planned for open cranial resection and can give informed consent are ideal candidates.
✕Probably not a fit
Patients who are pregnant or breastfeeding, prisoners, those currently on experimental or approved anti-EGFR therapies, or those with significantly abnormal liver or kidney tests may not receive benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional trial testing the safety and optimal dosing of ABY-029, an EGFR-targeted fluorescent Affibody, in adults with presumed high-grade intracranial tumors undergoing open craniotomy. Participants are assigned to one of two very low dose groups and receive ABY-029 prior to surgery. Surgeons use a specialized molecular fluorescence-guided imaging system during tumor resection to record drug uptake in the tumor and surrounding brain tissue. The primary focus is on safety and determining the dose that provides useful intraoperative visualization of tumor versus normal tissue.
Why it matters
Potential benefit: If successful, ABY-029 could help surgeons see tumor tissue more clearly during surgery, potentially improving the extent of tumor removal.
How similar studies have gone: Related fluorescence-guided surgery approaches and EGFR-targeted imaging agents have shown promise in early work, but ABY-029 is a novel Affibody approach that is still in early clinical testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of presumed high-grade glioma, based on image data. 2. Tumor judged to be suitable and planned for open cranial resection. 3. Valid informed consent by participant. 4. Age ≥ 18 years old. 5. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prisoners 2. Individuals who are pregnant or breast feeding. 3. Participants on any experimental or approved anti-EGFR targeted therapies 4. Elevated kidney or liver function tests (levels greater than 2.5 times the normal limit) from laboratory tests conducted as part of standard-of-care screening of prospective surgical participants no earlier than 30 days prior to surgery. 5. Any condition which, in the opinion of the clinical investigator, contraindicates research participation.
Where it's running
-
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting
Study contacts
- Principal investigator: Linton Evans, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Keith D Paulsen, PhD
- Email: keith.d.paulsen@dartmouth.edu
- Phone: 603-646-2695
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.