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ABY-029 Glioma Trial

Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• ABY-029 (drug)

Sponsor: Dartmouth-Hitchcock Medical Center · Participants: 33 · Started: Feb 17, 2026

Contact the study team

• Keith D Paulsen, PhD · Phone: 603-646-2695

Official record on ClinicalTrials.gov — NCT07063693

Locations in the U.S.

Conditions

• Brain Tumors

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.