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Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

An Open-Label, Two-Cohort Exploratory Phase II Study of Vebrekotuzumab With or Without PD-1 Inhibitor Immunotherapy in Patients With Advanced Esophageal Squamous Cell Carcinoma Refractory to First-Line Therapy

NCT07403136•Fudan University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing to voluntarily sign the informed consent form and comply with the protocol requirements.
•2. Age ≥18 years on the day of signing the informed consent form, regardless of gender.
•3. Life expectancy ≥12 weeks.
•4. Patients with histologically confirmed advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC) and immunohistochemistry (IHC) confirmed positive epidermal growth factor receptor (EGFR) expression (IHC 1+, 2+, or 3+).
•5. Have experienced disease progression or intolerability after receiving at least one prior line of systemic therapy, which must have included an immune checkpoint inhibitor (e.g., anti-PD-1/PD-L1 antibody).
•6. The patient must be able to provide a tumor tissue sample (paraffin block, paraffin-embedded sections, or fresh tissue sections) from the primary or metastatic site for pathological testing. Archived tumor tissue from the most recent treatment should be used. If archived tissue is unavailable, a new biopsy must be performed.
•7. Must have radiographic evidence of disease progression confirmed by the investigator during or after the last treatment regimen. At baseline, there must be at least one measurable extracranial lesion per RECIST 1.1 criteria (longest diameter ≥10 mm on CT scan, or for lymph nodes, short axis ≥15 mm). The measurable lesion should not have been previously irradiated, unless it is within a prior radiation field or was previously treated locally and has documented progression.
•8. All adverse events (AEs) from prior anti-tumor therapy have resolved to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 (except for alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
•9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to the first dose.
•10. No serious cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50% confirmed by echocardiography or MUGA scan within 28 days prior to the first dose.
+6 more criteria

Exclusion Criteria

•1. History of other primary malignancies. Note: Except for adequately treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; or patients with other malignancies who have undergone curative treatment and have been disease-free for ≥5 years may be enrolled.
•2. Untreated or unstable parenchymal brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
•Note: Patients who have received local therapy for brain metastases may be enrolled if brain imaging shows stability for at least 28 days prior to the first dose, with no evidence of cerebral edema, and no requirement for corticosteroid therapy.
•3. Presence of uncontrolled third-space fluid (e.g., significant ascites, pleural effusion, or pericardial effusion) that cannot be managed by drainage or other methods. Patients who required drainage to control third-space fluid within 14 days prior to the first dose are excluded.
•4. Any severe or uncontrolled systemic disease, in the investigator's judgment, including poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg), poorly controlled diabetes mellitus, or active bleeding signs, etc.
•5. Poorly controlled cardiac disease, including heart failure of New York Heart Association (NYHA) class ≥II, unstable angina, myocardial infarction within the past year, clinically significant supraventricular or ventricular arrhythmia requiring treatment, or long QT syndrome, e.g., QTcF \>450 ms (male) or QTcF \>470 ms (female).
•6. Evidence of active infection, including Hepatitis B (HBsAg positive AND HBV DNA ≥2000 IU/mL, excluding drug-induced or other causes of hepatitis), Hepatitis C (anti-HCV antibody positive AND HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection; or uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections, unless treated and resolved prior to study drug administration.
•7. History of hypersensitivity to any component of vebrekotuzumab (histidine, histidine hydrochloride, sucrose, mannitol, polysorbate 80) OR history of ≥Grade 3 hypersensitivity reactions to macromolecular protein agents/monoclonal antibodies.
•8. History of primary immunodeficiency or active autoimmune disease requiring systemic immunosuppressive therapy or systemic corticosteroid therapy (at doses ≥10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
•Note: Patients with type I diabetes mellitus, hypothyroidism managed with stable hormone replacement therapy (including that caused by autoimmune thyroid disease), psoriasis not requiring systemic therapy, or vitiligo may be enrolled.
+3 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

August 1, 2027

Completion Date

January 31, 2029

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Vebrekotuzumab

DRUG

PD-1 antibody

DRUG

Contacts

Kuaile Zhao, M.D.

CONTACT

+86-18017312534 kuaile_z@fudan.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

Inclusion Criteria

Exclusion Criteria

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