A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

NCT03154411 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: D16143
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Soft-tissue Sarcoma

Keywords

ABY-029; Affibody; molecular fluorescence-guided surgery; Epidermal Growth Factor Receptor (EGFR)

Outcome Measures

Primary Outcomes (1)

• Signal detection

  Following tumor excision, the tumor will be inked and sectioned and imaged using a near-infrared scanner and fiber-probe based system. Quantitative measurements of fluorophore concentration will be measured for tumors with EGFR pathology score ≥ 1 and compared to those with EGFR pathology score \< 1.

  Day of surgery, up to 1 week after surgery

Secondary Outcomes (2)

• Correlation of spatial patterns of EGFR expression

  within 1 week of surgery

• molecular uptake and ABY-029 concentration

  within 1 week of surgery

Study Arms (1)

ABY-029

EXPERIMENTAL

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

Drug: ABY-029

Interventions

ABY-029 DRUG

A minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma will be enrolled. Initial diagnostic biopsy specimens will be analyzed for EGFR positivity (an EGFR pathology score ≥ 1) by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery.

Also known as: ABY-029 trifluoroacetate salt, IRDye® 800CW Maleimide labeled Affibody peptide

ABY-029

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative histological diagnosis of primary sarcoma.
• Tumor judged to be suitable for open surgical resection based on preoperative imaging studies.
• Valid informed consent by subject.
• Age ≥ 18 years old.

You may not qualify if:

• Pregnant women or women who are breast feeding.
• Patients on any experimental anti-EGFR targeted therapies, either investigational or FDA approved.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

ABY-029

Study Officials

• Eric R Henderson, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: August 30, 2017
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)