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New drug cocktail aims to shrink head and neck tumors before surgery

NCT ID NCT07381075

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This phase 2 trial tests a drug called becotatug vedotin, given alone or with immune-boosting drugs (penpulimab or ivonescimab), before surgery for head and neck cancer. The goal is to see if these treatments can shrink tumors or even make them disappear completely. The study involves 120 people with resectable, locally advanced head and neck squamous cell carcinoma who have not had prior treatment.

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 (a drug that targets cancer cells) combined with or without immune checkpoint inhibitors (penpulimab or ivonescimab)
What this could lead to
If successful, this could lead to a new treatment option that shrinks head and neck tumors before surgery, potentially improving outcomes.
What could go wrong
This is an early phase 2 trial with only 120 people, so results may not apply to everyone. The drugs can cause side effects like immune reactions or organ damage.

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 90 people

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

Started

Jul 2026

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 70 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: 1. Age: 18 - 70 years old, gender not restricted; 2. Histopathologically diagnosed as squamous cell carcinoma of the head and neck (including oral cancer, laryngeal cancer, hypopharyngeal cancer, and oropharyngeal cancer, etc.); 3. Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC); 4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 5. Have not received any treatment for head and neck squamous cell carcinoma before, including drug treatment, radiotherapy, surgical treatment, etc.; 6. No distant metastasis; 7. The patient has the intention for radical treatment; 8. Good hematopoietic function (total white blood cell count ≥ 3.0×109 /L, absolute lymphocyte count ≥ 0.8×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109 /L, hemoglobin ≥ 90g/L) and no blood transfusion or biological response modifiers (such as granulocyte growth factors, erythropoietin growth factors, etc.) treatment within 14 days before the first administration; 9. Good liver function (total bilirubin (TBIL) ≤ 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5×ULN; serum albumin ≥ 28 g/L); 10. Good renal function (serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula), urine protein less than 2+, or 24-hour urine protein quantification \< 1g); 11. Good cardiac function, that is, normal electrocardiogram or abnormal without clinical significance, and echocardiography shows left ventricular ejection fraction (left ventricular ejection fraction, LVEF) ≥ 50%; 12. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, if the subject is receiving anticoagulation treatment, as long as the PT is within the range of the anticoagulant drug plan, it is acceptable; 13. During the screening period, blood pressure is well controlled (defined as systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg), and there is no change in antihypertensive treatment within 1 week before the first administration of the study drug; 14. Patients with HBV infection who can detect HBV deoxyribonucleic acid (DNA) levels (≥ 10IU/mL or above the detection limit) must receive antiviral treatment before randomization according to the clinical institution practice to ensure adequate viral suppression. Patients must maintain antiviral treatment during the study and within 6 months after the last study treatment administration. Patients with positive Anti-HBc detection but no HBV DNA ( \< 10IU/mL or below the detection limit) do not require antiviral treatment, unless HBV DNA exceeds 10IU/mL or above the detection limit during the treatment period; 15. Male patients with fertility and women of childbearing age who are willing to take effective contraceptive measures from signing the informed consent form to the last administration of the study drug within 6 months; women of childbearing age include pre-menopausal women and post-menopausal women within 1 year. The blood pregnancy test result of women of childbearing age within ≤ 7 days before the first administration of the study drug must be negative; 16. The subject voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-up. Exclusion Criteria: 1. Has received any form of anti-tumor treatment before; 2. Patients with allergic constitution and congenital immune deficiency; 3. Has undergone organ transplantation before; 4. Has a history of severe bleeding tendency or coagulation dysfunction; had significant clinical bleeding symptoms within 1 month before the study treatment, including but not limited to gastrointestinal bleeding and hemoptysis; had continuous anticoagulation treatment within 10 days before the study treatment; 5. Has experienced thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 6 months before the study treatment; 6. Has active autoimmune or inflammatory diseases, or has a related history, including inflammatory bowel disease (such as colitis or Crohn's disease), diverticulitis (except diverticular disease), systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome (such as granulomatous vasculitis, Gray's disease, rheumatoid arthritis, pituitary inflammation and uveitis). There are the following exceptions: patients with vitiligo or alopecia; patients with stable hypothyroidism after hormone replacement therapy (such as after Hashimoto's thyroiditis); any patients with chronic skin diseases that do not require systemic treatment; patients who can be included within the past 5 years without active diseases, but only after consultation with the study doctor; 7. Active infections, including tuberculosis or human immunodeficiency virus (HIV 1/2 antibody positive); 8. Uncontrolled complications, including but not limited to: receiving study treatment for persistent or active infections (except HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal diseases with diarrhea, or conditions that may limit compliance with study requirements, increase the risk of adverse events or affect the subject's ability to provide written informed consent; 9. Pregnant or lactating women; 10. The patient does not agree to use effective contraceptive measures during the treatment period and within the following 3 months; 11. Patients participating in other clinical studies simultaneously; 12. Patients with critical conditions unable to complete the survey; 13. Other primary malignant tumor history, but the following situations are excluded: malignant tumors treated for curative purposes, and having no known active diseases for ≥ 5 years before the study treatment and a low potential risk of recurrence; fully treated non-melanoma skin cancer or benign lentigo-like nevus without evidence of disease; fully treated carcinoma in situ with no evidence of disease; 14. Patients with a history of mental illness (such as schizophrenia, mania, anxiety disorder, depression, phobia, etc.) or patients diagnosed with mental illness during the clinical trial enrollment or their spouses; 15. Patients with communication disorders due to confusion, aphasia, or intellectual disability caused by reasons such as communication barriers or inability to answer normally; 16. Patients with other malignant tumor diseases; 17. Has a ≥ 3-grade allergy history to any component of vebecotota monoclonal antibody and/or pannipil monoclonal antibody injection and/or ivosizumab monoclonal antibody injection; 18. The investigator considers that there are other factors that are not suitable for inclusion or that may affect the subject's participation or completion of the study.

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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

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • West china hospital

    RECRUITING

    Chengdu, Sichuan, 610000, China

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