NCT07063693PHASE1Recruiting
ABY-029 Glioma Trial
Dartmouth-Hitchcock Medical Center
Start Date
2/17/2026
Completion Date
12/31/2028
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 Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
ABY-029
Conditions
Intracranial Tumor
Locations
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States