ABY-029 Head & Neck Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABY-029.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 1 Trial of ABY-029 Fluorescence in Patients With Head and Neck Squamous Cell Carcinoma
Overview
The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach head and neck squamous cell carcinomas (HNSCC) so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.
Interventions
- Drug ABY-029
ABY-029 will be administered via single intravenous injection to subjects with HNSCC approximately 1-3 hours prior to surgery. All research procedures will occur during surgery. The research procedures involve image and measurement data collection and biopsy specimen sampling. Research data collection will occur at 3 or 4 time points during surgery using either standard-of-care tools and methods or non-significant risk experimental devices. No follow-up visit will be required of participants.
Primary outcome measures
- Adverse events related to ABY-029 [Time frame: one month]
- Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens [Time frame: up to three months]
Eligibility criteria
Inclusion criteria
- Preoperative diagnosis of head and neck squamous cell carcinoma with planned surgical resection of the oral cavity, oropharynx, larynx, or hypopharynx.
- Tumor judged to be operable.
- Valid informed consent by participant.
- Age ≥ 18 years old.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients with a medical history of (Grade 2 or higher) hepatic/renal function compromise.
- Prisoners
- Individuals who are pregnant or breast feeding.
- Patients on experimental or approved anti-EGFR targeted therapies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07279116 · 02002698 · R01CA167413