A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

Dartmouth Health

Status and phase: Completed; Early Phase 1

Conditions: Primary Soft-tissue Sarcoma

Treatments: Drug: ABY-029

Study type: Interventional

Funder types: Other

Identifiers

NCT03154411

D16143

Details and patient eligibility

About

The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to detectable signals (defined as signal-to-noise ratio, SNR ≥10, with the Odyssey NIR scanner in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining and compare SNR to tissues with an EGFR pathology score < 1).

The secondary study objective is to assess if the spatial patterns of EGFR expression correlate with the tumor targeting of ABY-029 detection by NIR scanner 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 to enroll a minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma in this open label, single center, clinical trial of ABY-029. The study will enroll patients with an EGFR pathology score ≥ 1.

Initial diagnostic biopsy specimens will be analyzed for EGFR positivity by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery. Following tumor excision, the tumor will be transported to the Pathologist and will be inked and sectioned. Following sectioning the tumor will be imaged using near-infrared imaging systems. Quantitative measurements of fluorophore concentration will be measured for tumors with EGFR pathology score ≥ 1 and compared to those with EGFR pathology score < 1. Quantitative mapping of fluorophore concentration will be correlated with local EGFR concentration and blood vessel density. Upon specimen analysis, fluorophore measurements will be taken from normal, marginal tissues (e.g. skeletal muscle, adipose) in addition to the tumor. Average EGFR concentration and blood vessel density will be determined for each tumor through histological analysis of sections by routine sarcoma protocol and analysis guided by regional variations in ABY-029 concentration based upon near-infrared scan results.

The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned tumor resection during the surgical procedure.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Preoperative histological diagnosis of primary sarcoma.
2. Tumor judged to be suitable for open surgical 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, either investigational or FDA approved.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

ABY-029

Experimental group

Description:

ABY-029 will be administered prior to surgery and tissue will be examined ex vivo to determine binding with EGFR positive tumor tissue.

Treatment:

Drug: ABY-029