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Can a Two-Drug punch shrink oral tumors before surgery?

NCT ID NCT07766889

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether giving two drugs before surgery can help people with advanced oral cavity cancer. The drugs, becotatug vedotin and pucotenlimab, are designed to attack cancer cells and boost the immune system. Participants receive three cycles of the combination, followed by surgery to remove the tumor. The study aims to see if this approach can significantly reduce the tumor before surgery, potentially improving long-term outcomes and allowing some patients to receive less intensive radiation.

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 (MRG003) plus pucotenlimab (HX008)
What this could lead to
If successful, this approach could shrink oral cavity tumors before surgery, potentially improving survival and allowing less intensive radiation afterward.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The drug combination may cause side effects, and the treatment might not improve outcomes as hoped.

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 32 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

Dec 2028

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: * Voluntary participation with written informed consent, good compliance, and willingness to complete follow-up. * Age ≥18 years and ≤70 years, regardless of gender. * ECOG performance status score of 0 or 1. * Histopathologically confirmed, previously untreated, primary oral cavity squamous cell carcinoma (OSCC); central laboratory-confirmed PD-L1 Combined Positive Score (CPS) ≥1; clinical stage III-IVA (AJCC 8th edition) with potential for curative surgical resection as assessed by the investigator; no evidence of definite locoregional residual or distant metastasis. * Adequate organ function within 14 days prior to the first dose, without transfusion or hematopoietic growth factor support: * Bone marrow: ANC ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. * Liver: TBIL ≤1.5×ULN; AST/ALT ≤3.0×ULN; ALP ≤2.5×ULN; serum albumin ≥28 g/L. * Kidney: creatinine clearance (Ccr) ≥40 mL/min (calculated by Cockcroft-Gault formula) or serum creatinine ≤1.5×ULN. * Coagulation: INR ≤1.5×ULN and APTT ≤1.5×ULN (excluding patients receiving therapeutic anticoagulation). * Cardiac: LVEF ≥50% with no significant cardiac dysfunction. * Negative serum pregnancy test within 7 days prior to the first dose for women of childbearing potential; all fertile male and female participants must agree to use highly effective contraception from signing of informed consent through 1 year after the last dose of Pucotenlimab. Exclusion Criteria: * Age \>70 years or \<18 years. * History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. * HIV infection. * HBsAg positive with HBV DNA \>200 IU/mL or 1000 copies/mL. * HCV antibody positive. * Severe concurrent diseases that may pose significant risks or affect trial compliance, including unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \>1.5×ULN), severe cognitive impairment, or psychiatric disorders. * Active pulmonary tuberculosis infection within the past 1 year, or history of active tuberculosis \>1 year ago unless documented prior standard anti-tuberculosis treatment. * History of interstitial lung disease. * Active, known, or suspected autoimmune disease. Exceptions: type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia). * Systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days prior to signing informed consent. Patients receiving ≤10 mg/day prednisone equivalent or inhaled/topical corticosteroids are eligible. * Live vaccination within 30 days prior to signing informed consent or planned during the study. * Prior surgery, chemotherapy, radiotherapy, immunotherapy, or other anti-tumor therapy for head and neck cancer (excluding diagnostic procedures). * Known hypersensitivity to macromolecular protein preparations, or any component of Becotatug vedotin, Pucotenlimab, or cisplatin. * Pregnancy, lactation, or anticipated pregnancy during the study period.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms oral cavity 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

    2 sites. 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

  • Hospital of Stomatology, Sun Yat-sen University

    Guangzhou, Guangdong, 510055, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

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