ABY-029 for High-Grade Glioma Surgery

This study is testing a drug called ABY-029 in people with high-grade glioma (a type of brain tumor). The main goals are to see if ABY-029 is safe and to figure out the best amount to use so surgeons can see the tumor more clearly during surgery. You would receive ABY-029 through an IV right before your planned tumor removal surgery. Researchers will then use a special imaging system during surgery to measure the drug in your tumor and surrounding tissue. The study is looking for 33 participants aged 18 or older who have a high-grade glioma suitable for surgery and are able to give informed consent. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 33 participants. It compares two groups receiving different, very small amounts of ABY-029.
What's involved
You would receive ABY-029 via IV injection 1-3 hours before surgery. All research procedures, including image and measurement data collection and biopsy sampling, occur during surgery.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for adverse events related to ABY-029 for one month. They will also assess the false negative rate of ABY-029 fluorescence for up to three months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07063693

ABY-029 Glioma Trial

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Dartmouth-Hitchcock Medical Center
~33 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:ABY-029

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events related to ABY-029
Measured over One month
+1 more outcome measured
Intracranial Tumor
1 sites across 1 states
New Hampshire1
  • Linton Evans, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

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  • Adverse events related to ABY-029One month

    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.

  • False negative rate of ABY-029 fluorescenceUp to three months

    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.