A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery

NCT03282461 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: D17064
• 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 wide-field iFI) in sampled tissues with an EGFR (epidermal growth factor receptor) pathology score ≥ 1 based on histological staining. The secondary study objective is to assess ex vivo the specificity of tumor binding in resected specimens by measuring the corresponding molecular uptake and concentrations using histopathology.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Signal detection

  For each pathology, predictive models of the odds of tumor positivity for biopsies given concentration of ABY-029 will be constructed. Histologically confirmed tumor status from biopsies will be statistically analyzed against the predictive models. The quantitative fluorescence measures will also be assessed for their fit with statistics. The predictive accuracy of the model fit will be summarized through an index.

  Day of surgery, up to 1 week after surgery

Secondary Outcomes (1)

• Correlation of spatial patterns of EGFR expression

  within 1 week of surgery

Study Arms (1)

ABY-029

EXPERIMENTAL

Between 3-9 patients will be administered ABY-029 as a single intravenous injection approximately 1-3 hours prior to surgery.

Drug: ABY-029

Interventions

ABY-029 DRUG

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 operable head and neck cancer approximately 1-3 hours prior to 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 diagnosis of head and neck cancer.
• Tumor judged to be operable based on preoperative imaging studies.
• Valid informed consent by subject or subject's Legally Authorized Representative.
• 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

Conditions

Head and Neck Neoplasms

Interventions

ABY-029

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Joseph A Paydarfar, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: open label

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: January 24, 2018
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)