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New drug combo shows promise in shrinking head and neck tumors before surgery

NCT ID NCT07492914

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether giving two drugs (lucanoximab and tagolimab) before surgery can shrink tumors in people with head and neck cancer. Thirty adults with resectable cancer will receive the drugs intravenously every two weeks for two cycles, then undergo surgery. Researchers will measure how many patients have a major response in their tumor tissue and track side effects.

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 30 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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 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: * Aged 18 years and above, of any gender. * Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. * Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin ≥8 g/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) \>60 mL/min; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN. * Voluntarily participate in the study, sign the informed consent form, and be able to comply with scheduled study visits and relevant procedures in the protocol. Exclusion Criteria: * A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ). * Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome. * A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs. * Prior anti-tumor treatment involving anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy. * Receipt of a live infectious vaccine within 4 weeks prior to the first dose or planned vaccination during the study period; major surgery or severe trauma within 4 weeks prior to the first dose. * Systemic use of corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressants within 14 days prior to the first dose (inhaled or topical steroids and adrenal replacement therapy are permitted). * Severe medical conditions, including New York Heart Association (NYHA) class II or higher heart failure, ischemic heart disease, clinically significant arrhythmias requiring intervention, left ventricular ejection fraction (LVEF) \<50% on echocardiography, or prolonged QTc interval (males \>450 msec, females \>470 msec). * A known history of interstitial lung disease or high clinical suspicion of interstitial lung disease; active pulmonary tuberculosis or uncontrolled previous tuberculosis infection. * Hyperthyroidism or organic thyroid disease (patients with hypothyroidism under stable thyroid hormone replacement therapy are eligible for enrollment). * Active infection, unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within 1 week prior to signing the informed consent form. * Active hepatitis B (HBV DNA ≥2000 IU/ml or ≥10⁴ copies/ml), active hepatitis C (positive anti-HCV and HCV RNA above the lower limit of detection), positive HIV antibody, or a history of acquired immunodeficiency syndrome (AIDS). * A definite history of neurological or psychiatric diseases such as epilepsy or dementia. * A history of drug or alcohol abuse. * Pregnant or lactating females; patients (or their partners) planning pregnancy, having unprotected sexual intercourse, or refusing to take effective contraceptive measures during the study and for 3 months after study completion. * Receipt of other investigational drugs within 4 weeks prior to the first dose, or concurrent participation in other interventional clinical studies (observational or follow-up interventional studies are excluded). * Other circumstances deemed unsuitable for study participation by the investigator.

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Conditions

The condition(s) this trial relates to.

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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

More trials for these conditions

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