ABY-029 Glioma Trial

Summary

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

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.

Conditions2

Interventions1

Locations1 site

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