ABY-029 Head & Neck Trial

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT07279116
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABY-029 — DRUG
    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. Participants will be monitored for possible adverse events for approximately 30 days by the operating surgeon involved in the clinical trial procedures and through review of participant medical records.

Study Details

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.

Key Dates

First listed
Dec 12, 2025
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: ABY-029 6X dose group
    ABY-029 will be administered at the 6X dose level prior to surgery to participants with HNSCC. To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
  • Experimental: ABY-029 10X dose group
    ABY-029 will be administered at the 10X dose level prior to surgery to participants with HNSCC. To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.

Primary Outcome Measure

Adverse events related to ABY-029 [ Time Frame: one month ]

Central Contacts

Find similar trials

Nationwide
Head and neck cancer trialsOncology trialsENT trials

Related Studies