A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

Dartmouth Health

Status and phase: Completed; Early Phase 1

Conditions: Glioma

Treatments: Drug: ABY-029

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02901925

R01CA167413 (U.S. NIH Grant/Contract)

D16107

Details and patient eligibility

About

The primary study objective is to determine if microdoses of ABY-029 lead to detectable signals in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining.

The secondary study objective is to assess diagnostic accuracy of ABY-029 detection by iFI and intraoperative probe relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of ABY-029 in resected specimens.

Full description

The investigators plan a sample size of 6-12 patients in this open label, single center, clinical trial of ABY-029. Administration will occur as a single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery.

The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. Rather, doses have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery.
2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
3. Valid informed consent by subject.
4. Age ≥ 18 years old.

Exclusion criteria

1. Pregnant women or women who are breast feeding.
2. Patients on any experimental anti-EGFR targeted therapies

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

ABY-029 1X dose group

Experimental group

Description:

ABY-029 will be administered at the 1X dose level prior to surgery. Probe will be used in vivo to determine if signal is detectable, and ex vivo tissue pathology will measure extent of binding with EGFR positive tumor tissue.

Treatment:

Drug: ABY-029

ABY-029 3X dose group

Experimental group

Description:

ABY-029 will be administered at the 3X dose level prior to surgery. Probe will be used in vivo to determine if signal is detectable, and ex vivo tissue pathology will measure extent of binding with EGFR positive tumor tissue.

Treatment:

Drug: ABY-029

ABY-029 6X dose group

Experimental group

Description:

ABY-029 will be administered at the 6X dose level prior to surgery. Probe will be used in vivo to determine if signal is detectable, and ex vivo tissue pathology will measure extent of binding with EGFR positive tumor tissue.

Treatment:

Drug: ABY-029