Targeted drug combo aims to shrink Hard-to-Treat head and neck tumors

NCT ID NCT07683507

Disease control Sponsor: Feng Liu Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests a new drug, becotatug vedotin, combined with an immunotherapy (PD-1 inhibitor) in adults with advanced head and neck squamous cell carcinoma that cannot be surgically removed. The drug targets a protein called EGFR on cancer cells and delivers a toxin directly to them. The trial includes two groups: people who have not had prior treatment for advanced disease and those who have received at least one prior therapy. The main goal is to see how many participants' tumors shrink or disappear.

What this could mean

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

Active substance
becotatug vedotin combined with a PD-1 inhibitor
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced head and neck cancer, potentially shrinking tumors and delaying progression.
What could go wrong
This is an early-phase, single-arm study with only 60 participants. The drug may cause side effects, and results may not confirm benefit in larger trials.

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 60 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: * Age 18 to 80 years. * Primary tumor of head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma. * Disease assessed as not suitable for complete surgical resection, or the participant refuses surgery despite being considered technically eligible for surgery. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * No obvious contraindications to immunotherapy, radiotherapy, or chemotherapy. * Adequate major organ function, defined as follows: * Hematologic function: white blood cell count (WBC) ≥4.0 × 10\^9/L, absolute neutrophil count (ANC) ≥1.5 × 10\^9/L, platelet count (PLT) ≥100 × 10\^9/L, and hemoglobin (Hb) ≥90 g/L without blood transfusion, blood products, G-CSF, or other hematopoietic growth factors within 14 days before testing. * Biochemical function: serum albumin ≥3.0 g/dL (30 g/L), total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, and blood urea nitrogen (BUN) and serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min calculated by the Cockcroft-Gault formula. * Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN. For participants receiving anticoagulant therapy, PT must be within the intended therapeutic range of the anticoagulant. * Women of childbearing potential must use reliable contraception, have a negative pregnancy test within 7 days before enrollment, and agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. * The participant voluntarily agrees to participate in the study, signs the informed consent form, and is willing and able to comply with study visits and follow-up. Exclusion Criteria: * Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection; active hepatitis B infection, defined as HBV-DNA ≥10\^4 copies/mL; or hepatitis C infection, defined as positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay. * Known allergy to the study drug or any of its excipients, or a history of severe hypersensitivity reaction to other monoclonal antibodies. * Any of the following within 6 months before the first dose of study treatment: myocardial infarction, severe or unstable angina, New York Heart Association (NYHA) class II or higher heart failure, or symptomatic congestive heart failure. * Receipt of a live vaccine within 4 weeks before the first dose of study treatment. Inactivated injectable vaccines for seasonal influenza are permitted, but intranasal live attenuated influenza vaccines are not permitted. * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Known history of psychotropic drug abuse or illicit drug use. * Pregnant or breastfeeding women. * Diagnosis of any other malignancy within 5 years before study entry, except for locally treated and cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma. * Any other serious physical or psychiatric illness or laboratory abnormality that may increase the risk of study participation, interfere with study results, or make the participant unsuitable for this study in the investigator's judgment.

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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