ABY-029 Glioma Trial
ConditionIntracranial Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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
Qualifiers
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.
Disqualifiers
Prisoners
Individuals who are pregnant or breast feeding.
Participants on any experimental or approved anti-EGFR targeted therapies
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.
Trial design
Treatments tested in this trial
- ABY-029
Treatment groups
33 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov