RecruitingPhase 2NCT07403136

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


Sponsor

Fudan University

Enrollment

104 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted therapy called vebrekotuzumab — alone or combined with an immunotherapy drug — in people with advanced esophageal squamous cell carcinoma (cancer of the food pipe) who have already tried other treatments. The drug targets a protein called EGFR found on cancer cells. **You may be eligible if...** - You are 18 years or older - You have advanced or metastatic esophageal squamous cell carcinoma confirmed by biopsy - Your tumor tests positive for the EGFR protein (by a lab test called IHC) - You have already received at least one prior treatment including an immunotherapy drug (like a PD-1/PD-L1 inhibitor) and your cancer has progressed or you could not tolerate it - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have significant uncontrolled heart problems - You have active brain metastases - You have serious unresolved side effects from prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVebrekotuzumab

This two-cohort study investigates the novel combination of vebrekotuzumab (an EGFR-targeting ADC) with a PD-1 inhibitor versus vebrekotuzumab monotherapy in patients with advanced ESCC refractory to first-line therapy. It uniquely provides a head-to-head comparison to evaluate the synergistic potential of combining targeted cytotoxicity with immune checkpoint blockade in this specific, treatment-resistant population.

DRUGPD-1 antibody

The PD-1 inhibitor (e.g., pembrolizumab) will be used exclusively in Cohort 1 in combination with vebrekotuzumab. This combination is designed to simultaneously deliver targeted cytotoxicity and immune checkpoint blockade, exploring their potential synergy in patients with advanced ESCC who have progressed after first-line therapy.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07403136


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