Testing a new cancer drug alone or combined with immunotherapy for advanced head and neck cancer

Plain-English translation of NCT07408063 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing , a new type of cancer drug called an antibody-drug conjugate that targets a protein on the surface of cancer cells and delivers chemotherapy directly into them. Some participants will receive this medication alone, while others will receive it combined with , an immunotherapy drug. The goal is to understand why this treatment works for some patients but not others.

Head and neck cancer that returns or spreads is difficult to treat, and many patients eventually stop responding to standard therapies. This trial is designed to find out how well this new medication works and to identify which patients are most likely to benefit from it, as well as why some patients develop resistance to the treatment.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been diagnosed with squamous cell head and neck cancer that has returned locally or spread to other parts of your body, and is not treatable with surgery or radiation alone
you have at least one measurable tumor that can be seen on imaging scans
you are in good enough physical condition to tolerate treatment (ECOG performance status of 0 or 1)
you are willing to have tumor biopsies taken before and during treatment to help researchers understand how the medication works
for Cohort A: you have already been treated with previous chemotherapy and immunotherapy for your cancer; for Cohort B: you have not yet received any systemic chemotherapy for your recurrent or metastatic disease

You likely don't qualify if…

you have an active or past hepatitis B or C infection (unless your hepatitis C is undetectable)
you have a known history of HIV infection
you have ongoing, severe side effects from previous cancer treatments that have not recovered to Grade 1 or below
your head and neck cancer started in the nasopharynx, paranasal sinuses, or is of unknown primary origin
you have a non-squamous cell type of head and neck cancer, such as adenocarcinoma or salivary gland cancer

What participation looks like

You will receive intravenous infusions of the medication once every three weeks in 21-day cycles. Depending on which group you're assigned to, you'll either receive the medication alone (Cohort A) or combined with another medication (Cohort B). Treatment continues until your cancer progresses, you experience unacceptable side effects, or you choose to stop. You'll need to attend regular visits for blood tests, scans, and check-ups, and you'll have tumor biopsies taken at the start of the study and while on treatment. The entire study is expected to last about 40 months from start to finish.

AI-generated summary from trial data · Jun 18, 2026 · Not medical advice

Testing a new cancer drug alone or combined with immunotherapy for advanced head and neck cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)