Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07524452

Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Led by Ming-Yuan Chen · Updated on 2026-04-13

430

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .

CONDITIONS

Official Title

Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign the informed consent form
  • Histologically confirmed untreated head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS 21 1
  • Clinical stage III or IVA depending on tumor type and p16 status
  • Eligible for curative-intent surgery as determined by the surgeon
  • Age between 18 and 75 years
  • ECOG performance status of 0 or 1
  • Life expectancy greater than 6 months
  • At least one measurable lesion according to RECIST 1.1
  • Adequate organ function meeting specified laboratory criteria without recent blood transfusion or growth factors
  • Baseline left ventricular ejection fraction of at least 50% by MUGA scan or echocardiography
  • Women of childbearing potential agree to use contraception during treatment and for 3 months after
  • Good compliance
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of allergy to PD-1 inhibitors
  • History of other cancers within 5 years except certain cured skin, cervical, or thyroid tumors
  • Residual toxicity from prior cancer treatments except mild alopecia, fatigue, or grade 2 hypothyroidism
  • Uncontrolled heart conditions including NYHA Class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or significant ventricular arrhythmias
  • Grade 2 or higher peripheral neuropathy
  • Recent pulmonary embolism or deep vein thrombosis within 3 months
  • Active bleeding or blood clotting disorders or use of coumarin anticoagulants
  • Hypersensitivity to any component of vibecotamab or severe allergic reactions to prior anti-EGFR agents
  • Use of investigational drugs prior to study drug or participation in other clinical trials except observational studies
  • Use of systemic corticosteroids above specified doses within 2 weeks prior to study drug except for limited uses
  • Recent administration of live vaccines within 4 weeks or major surgery/severe trauma within 4 weeks before study drug
  • Severe infections or pulmonary inflammation within 2-4 weeks before study drug
  • Severe chronic lung diseases with respiratory failure or symptomatic bronchospasm
  • Active autoimmune diseases or syndromes except certain mild resolved conditions
  • History of immunodeficiency or organ/bone marrow transplantation
  • Active or recent tuberculosis infection without proper treatment
  • Active hepatitis B or C infection above specified viral levels
  • Uncontrolled fluid accumulation requiring frequent drainage
  • History of substance abuse, alcoholism, or drug use
  • Any condition judged by the investigator as inappropriate for inclusion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Fifth Affiliated Hospital,Sun Yat-sen University

Zhuhai, Guangdong, China, 519099

Actively Recruiting

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Research Team

M

Mingyuan Chen

CONTACT

R

Rui You

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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