Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07403136

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

Led by Fudan University · Updated on 2026-05-11

104

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will test a new potential treatment for advanced esophageal squamous cell cancer (ESCC) for patients whose initial treatment has stopped working. Currently, the standard second-line treatment for this cancer is PD-1 inhibitors or chemotherapy alone, which is not very effective, allowing the cancer to grow again after just 1.6 to 3.4 months on average. Therefore, there is a strong need for more effective therapies. The new treatment is a type of drug called an antibody-drug conjugate (ADC). It is designed to target a specific protein called EGFR, which is found in high amounts on the surface of 50-70% of ESCC cancer cells and is linked to a poorer outlook for patients. This ADC works like a targeted delivery system: an antibody guides a powerful cell-killing drug directly to the cancer cells, aiming to destroy them while reducing harm to healthy cells. Although other drugs targeting EGFR have not successfully improved survival for ESCC patients, this new ADC offers a different and promising approach. The main goal of this study is to find out if this new EGFR-targeting ADC is effective in helping patients with advanced ESCC live longer without their cancer getting worse.

CONDITIONS

Official Title

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to sign informed consent and follow study rules
  • Age 18 years or older
  • Life expectancy of at least 12 weeks
  • Diagnosed with advanced or metastatic esophageal squamous cell carcinoma with positive EGFR expression
  • Disease progressed or intolerable after at least one prior systemic therapy including immune checkpoint inhibitor
  • Able to provide tumor tissue sample from primary or metastatic cancer site for testing
  • At least one measurable extracranial tumor lesion per RECIST 1.1 criteria
  • Side effects from prior anti-cancer treatments have resolved to Grade 1 or less (except alopecia and minor lab abnormalities)
  • ECOG Performance Status of 0 or 1 within 7 days before first dose
  • No serious heart dysfunction; left ventricular ejection fraction 50% or higher
  • Adequate organ function including bone marrow, liver, kidney, and coagulation within 7 days before first dose
  • Male and female patients of reproductive potential agree to use effective contraception during and 6 months after treatment
  • Negative pregnancy test for women of childbearing potential within 7 days before first dose
Not Eligible

You will not qualify if you...

  • History of other primary cancers except certain treated skin, bladder, or cervical cancers or cured cancers disease-free for 5 years
  • Untreated or unstable brain metastases, spinal cord compression, meningitis, or leptomeningeal disease
  • Uncontrolled fluid buildup like ascites or effusions not manageable by drainage
  • Severe or uncontrolled systemic diseases including poorly controlled hypertension, diabetes, or active bleeding
  • Poorly controlled heart disease including recent heart attack or significant arrhythmias
  • Active infection including hepatitis B or C, HIV, or uncontrolled bacterial, viral, fungal, or parasitic infections
  • History of severe allergic reactions to vebrekotuzumab components or similar antibodies
  • Active autoimmune disease requiring systemic immunosuppressive or high-dose corticosteroid therapy recently
  • History of interstitial lung disease, radiation pneumonitis, severe lung diseases, or symptomatic bronchospasm
  • Pregnant or breastfeeding women or unwilling to use contraception during and 6 months after treatment
  • Any other condition making participation unsuitable in the investigator's opinion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Actively Recruiting

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Research Team

K

Kuaile Zhao, M.D.

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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