Clinical trial · Interventional
ABY-029 Glioma Trial
Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma
NCT07063693CI-TRIAL-00105177recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Tumor | Intracranial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABY-029 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABY-029 6X dose group
- description
- ABY-029 will be administered at the 6X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
- interventionNames
- Drug: ABY-029
- type
- EXPERIMENTAL
- label
- ABY-029 10X dose group
- description
- ABY-029 will be administered at the 10X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.