Early Phase 1
N=12
A Microdose Evaluation Study of ABY-029 in Recurrent Glioma
Glioma
Bottom Line
View on ClinicalTrials.gov: NCT02901925 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Fluorescence Signal Detection — 6.2; 5.0; 8.8 Biological variance ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- ABY-029 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fluorescence Signal Detection |
6.2; 5.0; 8.8 | — |
| SECONDARY Mean Tumor-to-background Ratio |
1.7; 2.1; 2.6 | — |
| SECONDARY Ex Vivo Fluorescence Intensity |
61.4; 215.2; 884.1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery.
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Valid informed consent by subject.
- Age ≥ 18 years old.
Exclusion Criteria
- Pregnant women or women who are breast feeding.
- Patients on any experimental anti-EGFR targeted therapies
Data sourced from ClinicalTrials.gov (NCT02901925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.