Head and Neck Squamous Cell CarcinomaPhase 1NCT07279116
ABY-029 Head & Neck Trial
A Phase 1 study testing ABY-029 in people with Head and Neck Squamous Cell Carcinoma, run by Dartmouth-Hitchcock Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- ABY-029
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 1 Trial of ABY-029 Fluorescence in Patients With Head and Neck Squamous Cell Carcinoma
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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- ABY-029
- Keywords
- ABY-029, Affibody, Molecular Fluorescence-Guided Surgery, Epidermal Growth Factor Receptor (EGFR)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABY-029Drug
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 group | Role | What they receive |
|---|---|---|
| ABY-029 6X dose group | Experimental | 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. Receives: Drug: ABY-029 |
| ABY-029 10X dose group | Experimental | 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. Receives: Drug: ABY-029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to ABY-029
To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.
Measured: one month
Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens
To measure the diagnostic performance of ABY-029, the diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens histologically confirmed as tumor from participants receiving the 6X microdose and 10X microdose.
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start30 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Twelve (12) participants with likely EGFR-positive tumors will be enrolled, alternating between two ABY-029 administration doses (the 6X dose and 10X dose), until a total of 24 participants have been enrolled.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joseph A. Paydarfar, Dartmouth-Hitchcock Medical Center
- Investigators
- Joseph Paydarfar, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279116
- Sponsor's protocol ID
- 02002698
- Other IDs
- R01CA167413
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of ABY-029 Fluorescence in Patients With Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07279116
- Acronym / sponsor ID
- 02002698
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- ABY-029, Affibody, Molecular Fluorescence-Guided Surgery, Epidermal Growth Factor Receptor (EGFR)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College, National Cancer Institute (NCI)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Twelve (12) participants with likely EGFR-positive tumors will be enrolled, alternating between two ABY-029 administration doses (the 6X dose and 10X dose), until a total of 24 participants have been enrolled.
| Arm | Type | Receives |
|---|---|---|
| ABY-029 6X dose group | Experimental | Drug: ABY-029ABY-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. |
| ABY-029 10X dose group | Experimental | Drug: ABY-029ABY-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABY-029ABY-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. | Drug | ABY-029 10X dose group, ABY-029 6X dose group |
Primary outcome
Adverse events related to ABY-029
Time frame: one month
To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.
Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens
Time frame: up to three months
To measure the diagnostic performance of ABY-029, the diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens histologically confirmed as tumor from participants receiving the 6X microdose and 10X microdose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Paydarfar, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABY-029 in people with Head and Neck Squamous Cell Carcinoma, run by Dartmouth-Hitchcock Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith D Paulsen, PhD (603-646-2695, keith.d.paulsen@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to ABY-029 (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.