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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ABY-029
DrugABY-029 will be administered via single intravenous injection to subjects with high-grade glioma approximately 1-3 hours prior to surgery. All research procedures will occur during surgery. The research procedures involve image and measurement data collection and biopsy specimen sampling. Research data collection will occur at 3 or 4 time points during surgery using either standard-of-care tools and methods or non-significant risk experimental devices. No follow-up visit will be required of participants. Participants will be monitored for possible adverse events for approximately 30 days by the operating surgeon involved in the clinical trial procedures and through review of participant medical records.
Treatment groups
33 Participants
are divided into 2 treatment groupsGroup A: ABY-029 6X dose groupExperimental treatment 1 intervention
Group B: ABY-029 10X dose groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events related to ABY-029
To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.
Time frame
One month2
False negative rate of ABY-029 fluorescence
To measure of diagnostic performance of ABY-029, the false negative rate of ABY-029 fluorescence measured during surgery in tissue samples that are confirmed to be tumor through pathology.
Time frame
Up to three monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov