OncoMatch/Clinical Trials/NCT07403136
Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC
Is NCT07403136 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Vebrekotuzumab and PD-1 antibody for esophageal squamous cell carcinoma.
Treatment: Vebrekotuzumab · PD-1 antibody — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: EGFR overexpression (IHC 1+, 2+, or 3+)
immunohistochemistry (IHC) confirmed positive epidermal growth factor receptor (EGFR) expression (IHC 1+, 2+, or 3+)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor (anti-PD-1 antibody, anti-PD-L1 antibody)
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).
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L. No blood transfusion or blood component therapy within 14 days prior to first dose, nor any biologic response modifiers (e.g., G-CSF, erythropoietin) within 7 days prior to first dose.
Kidney function
Serum creatinine (Cr) ≤1.5 × ULN, or calculated creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min.
Liver function
For patients without liver metastases: TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN. For patients with liver metastases: TBIL ≤1.5 × ULN; ALT and AST ≤5 × ULN.
Cardiac function
No serious cardiac dysfunction, with LVEF ≥50% confirmed by echocardiography or MUGA scan within 28 days prior to the first dose.
Adequate organ function within 7 days prior to the first dose, as defined by: Bone marrow: ANC ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L. Patient must not have received any blood transfusion or blood component therapy within 14 days prior to the first dose, nor any biologic response modifiers (e.g., G-CSF, erythropoietin) within 7 days prior to the first dose. Liver: For patients without liver metastases: TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN. For patients with liver metastases: TBIL ≤1.5 × ULN; ALT and AST ≤5 × ULN. Kidney: Serum creatinine (Cr) ≤1.5 × ULN, or calculated creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min. Coagulation: INR ≤1.5 × ULN and aPTT ≤1.5 × ULN (unless the patient is receiving therapeutic anticoagulation).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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