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Can a targeted drug combo outsmart advanced head and neck cancer?

NCT ID NCT07744126

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether adding an investigational drug called telisotuzumab adizutecan to the standard immunotherapy pembrolizumab can better control recurrent or metastatic head and neck squamous cell carcinoma. The study enrolls adults whose tumors express a specific protein (c-Met) and who have not yet received systemic treatment for advanced disease. Participants are randomly assigned to receive either the new combination or standard chemotherapy plus pembrolizumab. The goal is to see if the new combo improves tumor response and delays progression, while also assessing safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Telisotuzumab adizutecan in combination with pembrolizumab
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with recurrent or metastatic head and neck cancer, potentially improving response rates and delaying disease progression.
What could go wrong
This is an early-phase trial, so the benefits are not proven. The drug combination may cause side effects, and it is only being tested in patients whose tumors express a specific protein (c-Met), so results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable by local therapies. * Eastern cooperative oncology group (ECOG) performance status must be \<= 1. * Must have c-Met protein expression by central c-Met immunohistochemistry (IHC) staining at any intensity in \>= 25% tumor cells. * Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. * Must have had no prior systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Exclusion Criteria: * Have history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis on screening chest computed tomography (CT) scan. * Have any major, life-threatening conditions. * Life expectancy should be at least 3 months.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma neoplasm Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.