ABY-029 for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new drug called ABY-029, an imaging agent designed to help surgeons see brain tumors more clearly during surgery. The main goal is to assess the safety of ABY-029 and determine the optimal dose for illuminating tumors. Participants will be divided into two groups to receive different small doses of the drug. Suitable candidates have been diagnosed with a high-grade glioma, a type of brain tumor, and are planning surgery to remove it. As a Phase 1 trial, this research focuses on understanding how ABY-029 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that ABY-029 is likely to be safe for humans?
Research has shown that ABY-029 is generally safe for humans. In earlier studies, patients experienced no harmful effects from the drug at various dose levels, indicating no negative impact on the body. Importantly, ABY-029 was tested in people with soft-tissue sarcoma (a type of cancer) and did not cause any serious side effects. Another study on its use in brain cancer found that even at higher doses, ABY-029 caused no negative reactions. So far, it appears safe at the doses used for imaging during surgeries.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about ABY-029 for brain cancer because it offers a novel approach to targeting high-grade gliomas. Unlike traditional treatments like chemotherapy and radiation, which attack cancer cells more broadly, ABY-029 is a fluorescent tracer that helps surgeons see and remove tumor tissue more precisely during surgery. This new mechanism of action could potentially lead to more successful surgeries with less damage to healthy brain tissue, offering hope for better outcomes and fewer side effects for patients.
What evidence suggests that ABY-029 might be an effective treatment for brain cancer?
Studies have shown that ABY-029 holds promise for brain cancer imaging. It targets a protein called EGFR, often present in large amounts on brain tumors. Previous research demonstrated that ABY-029 effectively highlights these tumors, aiding visibility during surgery. This assists surgeons in identifying and removing tumors with greater accuracy. Early tests in humans and animals revealed that ABY-029 produces clearer images of tumors compared to normal brain tissue, suggesting its potential as a valuable tool in brain cancer surgeries. In this trial, participants will receive either a 6X or 10X dose of ABY-029 before surgery to assess its effectiveness in enhancing tumor visibility.12367
Who Is on the Research Team?
Linton Evans, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABY-029 at either 6X or 10X dose level prior to surgery, with blood, urine, and EKG monitoring
Follow-up
Participants are monitored for adverse events and diagnostic performance of ABY-029 fluorescence
What Are the Treatments Tested in This Trial?
Interventions
- ABY-029
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor
Dartmouth College
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
First-in-human Study of ABY-029, a Novel Fluorescent Peptide ...
When administered above the microdose, ABY-029 demonstrated high correlation to EGFR expression and contrast values that were encouraging for ...
Study Details | NCT07063693 | ABY-029 Glioma Trial
Inclusion Criteria: Clinical diagnosis of presumed high-grade glioma, based on image data. Tumor judged to be suitable and planned for open cranial resection.
RAPID COMMUNICATION: Optimizing Glioma Detection using ...
We have examined how the ABY-029 dose injected in rats affects the contrast seen in brain tumors. The results showed a linear dose-response relationship ...
4.
aacrjournals.org
aacrjournals.org/mct/article/24/5/784/761976/First-in-Human-Study-of-ABY-029-a-NovelFirst-in-Human Study of ABY-029, a Novel Fluorescent ...
ABY-029, an anti-EGFR Affibody molecule conjugated to IRDye 800CW, recently underwent first-in-human testing in soft-tissue sarcoma.
A Microdose Evaluation Study of ABY-029 in Recurrent ...
Second, while these processes provide reliable enhancement in high-grade glioma tumors, enhancement at the margin and in low-grade glioma is relatively poor.
A Fluorescent Anti-EGFR Synthetic Affibody Molecule ... - PMC
Single-dose ABY-029 produced no pathological evidence of toxicity at any dose level. No phototoxicity was observed in EGFR positive and negative glioma cell ...
anti egfr fluorescence imaging agent aby 029
Safety Data: To date, numerical data shows that the micro-dose levels used for imaging do not cause the systemic side effects typically seen ...
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